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Biologic Drugs

Capillary Electrophoresis

Chiral HPLC & SFC Method Development

Impurity Isolation and Identification

Method Development and Validation

Overview

Preparative Resolution Processes

Reference Substances / Qualification

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ACTA Laboratories Inc

AES Life Sciences

AMRI

APC Ltd

AbbVie Contract Manufacturing

Acceleration Laboratory Services

Admix Pharma Laboratories, LLC

Aizant Drug Research Solutions Pvt. Ltd.

AlbyPharma

Almelo Private Limited

Anacipher

Arbro Pharmaceuticals Pvt. Ltd

Arevipharma GmbH

Ascent Innovative Medicines

Ash Stevens, Inc.

AvacaPharma

BLUEPHARMA - INDUSTRIA FARMACEUTICA, S.A

Basic Pharma

Bio-Technology General Israel Ltd.

BirgiMefar Group

Boston Analytical

CARBOGEN AMCIS AG

CLEARSYNTH LABS LIMITED

CU Chemie Uetikon GmbH

Cambrex Corporation

Cayman Chemical Company Inc.

Cebiphar

ChemCon GmbH

Chemtos

Crenza Pharma

Curida AS

Cyndea Pharma S.L

DPT Laboratories, Ltd

Dishman Carbogen Amcis

Diverchim S.A.

Etico Lifesciences

Eutech Scientific Services Inc

Famar S.A.

Farmak A.S

Farmhispania, S.A.

Fermion Oy

Flagship Biotech International Pvt. Ltd

Fresenius SE & Co. KGaA

GALENIX INNOVATIONS

GALIEN LPS

GRAM Laboratory Inc

GVK Biosciences

GfM mbH Gesellschaft fur Micronisierung mbH

Globela Pharma Pvt. Ltd.

Kantisto BV

KriSan Biotech

Labiana Life Sciences S.A

Legacy Pharmaceuticals Switzerland

M2I Life sciences

M2M Pharmaceuticals Ltd

Maithili Life Sciences Private Limited

Malladi Drugs & Pharmaceuticals Limited

Megsan Labs Private Limited

Menadiona, S.L.

Merck Millipore

Mithra CDMO

Nanjing Dorra Pharmaceutical Technology Co.,Ltd

Neopharm Labs Inc

Neuland Laboratories Inc

Novick Biosciences

Nutrasource

ORIT LABS LLC

Olive Healthcare

One Pharma S.A

PCI Pharma Services

PCI Synthesis

PHARMATHEN INDUSTRIAL SA

PSR Pharma Science and Research

PYRAMID Laboratories, Inc

Pace Analytical Services, LLC

Particle Sciences

Pfanstiehl, Inc

PharmaVize NV

Pierre Fabre CDMO

Primera Analytical Solutions Corp

Progenerics Pharma Pvt Ltd

QUINTA-ANALYTICA s.r.o

Quantex Laboratories

RD Laboratories

RECRO GAINESVILLE LLC

Rafarm S.A

Ropack Inc

SEQUENT SCIENTIFIC LTD

STABICON LIFE SCIENCE PVT LTD

Saneca Pharmaceuticals

Santa S.A

ScinoPharm Taiwan, Ltd.

Servier CDMO

Shijiazhuang Rainbowlabs Pharmaceutical Technology Co.Ltd

Siegfried AG

Skyepharma

Sofarimex

Softigel Procaps

Stason Pharmaceuticals, Inc.

Sushen Medicamentos Pvt. Ltd

Tepnel Pharma Services

UPM Pharmaceuticals

UQUIFA

Unither Pharmaceuticals

Vitas Analytical Services

ZACH SYSTEM SPA

ZCL CHEMICALS LTD

Zenvision Pharma LLP

mKnal Global Solutions

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Virtual Booth Quinta-Analytica, a leading Central European one-stop-shop CRO located in Czech Republic. Providing end-to-end solution to its partners

Nordic Life Science Days

Method Transfer & Validation

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Methods transfers are performed according to the GMP procedures and approved method transfer protocols. Similarly, method validations are also strictly performed according to the GMP procedures and approved validation protocols.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Virtual Booth Expert and Agile CDMO Partner for tailor-made solutions.

CPhI Worldwide

Stand No.120D75

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Analytical Method Development

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Skyepharma's analytical experienced team supports the pharmaceutical development during every phase of the development process. Analytical validation, characterization capabilities, stability analysis, ICH Q3D and E/L capabilities.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Overview

Virtual Booth Expert and Agile CDMO Partner for tailor-made solutions.

CPhI Worldwide

Stand No.120D75

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Analytical Development & Expertise

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Skyepharma's analytical experienced team supports the pharmaceutical development during every phase of the development process. Analytical validation, characterization capabilities, stability analysis, ICH Q3D and E/L capabilities.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Virtual Booth Development, production, marketing of APIs, Intermediates & specialities// FDA inspected.

CPhI Worldwide

Booth No. 40H02

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Analytical Methods & Equipment Validation

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Our analytical centre provides these methods & equipment: Analytical methods and equipment are validated; LCMS, GCMS, HPLC, TLC; UV/VIS and IR spectrometry; Capillary electrophoresis; Thermal analysis – DSC, Calorimetry; NMR (400 MHz) + xRAY; PSD analysis

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Virtual Booth 100% Export Oriented R&D Center & cGMP facility// Broad range of advance fine chemical intermediates & APIs

Pharma ChemOutsourcing

Analytical Method Development & Validation

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State-of-the-art R&D center is located in our Ankleshwar facility. Highly qualified professionals with the scientific bent of mind are working in product development, analytical development and intellectual property rights.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Virtual Booth A partner for the pharma and biotech industries to improve patient outcomes & quality of life

CPhI Worldwide

Booth No. 80K30

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Analytical Method Development & Validation

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AMRI specializes in biochemical method development, transfer and validation for the analyses of biological products and biosimilars by HPLC, UPLC, LC-MS, MALDI-TOF MS, NMR and assays.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Biologic Drugs

Virtual Booth Global leader for science based integrated drug development solutions

Analytical Method Development

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With our vast experience we add exponential value to our client’s R&D programs at every stage of the drug development. We serve as a vital link between the pharmaceutical companies and the healthcare industry.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Virtual Booth USFDA, EDQM, ANSM, KFDA, TGA Inspected// in 60 countries // Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl

CPhI Worldwide

Booth No. 40K20

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Analytical Method Development & Validation

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Malladi’s Research & Development is well-equipped with a wide range of process & analytical capabilities such as method development & specification development for raw material/API, method validation, impurity identification and stability studies.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Impurity Limit Testing (Melamine, Food Toxins...

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Employing multiple chemical testing methods, we perform qualitative/quantitative analysis, purification, & characterization of chemical entities such as natural products, synthetic compounds, cosmetics, pharmaceuticals, & drugs of abuse from organic & biological matrices.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Impurity Isolation and Identification

Virtual Booth Pioneers in Development & Manufacturing Solutions

American Pharma Outsourcing Summit

Method Development (Assay, Impurities, Dissol...

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To help you achieve the desired quality and performance of your compound, Recro’s veteran scientists customize solutions for your complex products. Our team adheres to global ICH guidelines to ensure the development of safe, effective, high-quality pharmaceutical products.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Virtual Booth Offering Full Spectrum of services from early stage of synthesizing potential NCE's to Large-Scale Commercial Operation.

CPhI Worldwide

Booth No. 40C20

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Analytic Methods Development & Validation

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ScinoPharm's comprehensive analytical services include purity testing, characterization of polymorphs, analytic methods development and validation, as well as stability testing. All analytical instruments and data are managed through the company's Laboratory Information Management System

- Directory Listing

Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Virtual Booth Unither Pharmaceuticals, a world-leading pharmaceutical contract development manufacturing organization (CDMO)

Contract & Outsourcing Conference

Method Development

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Unither can provide provide standalone pharmaceutical R&D services such as analytical methods validation, ICH stability studies, clinical batch manufacture, and clinical primary packaging.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Virtual Booth Chemistry for a better life

CPhI Middle East & Africa

Analytical Method Validation

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Uquifa offers the opportunity to manage the development activities of any drug life cycle by offering services on DMF/CTD/COS application, stability studies, process validation and analytical method validation, working standard supply or impurity

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Virtual Booth Energise your science for life

Analytical Services for Material Characteriza...

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Dishman's analytical services support both process control and material characterisation for laboratory and production chemistry from initial raw material release to release of the final APIs.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Impurity Isolation and Identification

Impurity Profiling & Identification

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Carbogen Amcis SAS state-of-the-art infrastructure includes process research and development (PR&D) laboratories, one laboratory dedicated to conjugation of small and large molecules and manufacturing capabilities.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Impurity Isolation and Identification

Virtual Booth The 2nd largest dermo-cosmetics laboratory in the world and the 2nd largest private French pharmaceutical group.

Process & Analytical Methods Validation

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Pierre Fabre Value Chain For Production of Your Drugs: Industrialization (Process optimization on pre-industrial scale, Pilot and clinical batches production, Process and analytical methods validation).

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Virtual Booth Committed to providing Highly Customized Solutions for all your Development Programs.

Analytical Development

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Analytical development (UV/CAD/RID-HPLC, GC, HS-GC), structural characterization (GC-MS, HPLC- MS, NMR, IR)

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Analytical Method Development & Evaluation

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Softigel's seven cutting-edge facilities house a fully integrated PDS unit and covers all product life cycle phases from early development to commercial in the same plant, using equipment replication between non GMP and GMP.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Analytical Method Development & Validation

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Pharmathen’s R&D activities have been vertically intergraded including Research and Development of Active Pharmaceutical Ingredients (APIs). Both labs are outfitted with the most technologically advanced and state of the art instrumentation and equipment.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Analytical Method Validation 

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We undertake method validation studies as per ICH guidelines. This includes analytical method validation of compendial and non compendial chromatographic method. We also undertake project for analytical method development and validation for cleaning procedures.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Analytical Method Development, Validation & T...

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Acceleration Laboratory Services is the foremost Contract Solutions Provider for the pharmaceutical research. The ultimate goal for our associates is to deliver superior solutions to our clients, on time, and on point, while maintaining a fun and empowering work environment.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Method Development, Optimization & Validation

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Our laboratories, equipped with the most modern instrumentation is operated by a well trained and highly motivated staff with an average of over 10 years of practical experience. The Pharmaceutical Analytical Laboratory is GMP inspected and under control of the respective authorities.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Method Development & Validation

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- Service Details

Our testing services are performed using USP/EP guidelines in compliance with FDA and DEA guidelines. Our laboratory is continually updated with new equipment to adapt to changing regulations and the ongoing needs of our clients.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Develop & Validate New Analytical Methods

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We provide full QC support - physical, chemical, and microbiological - for starting materials, finished products, and in-process control. In-house expertise is available to develop and validate new analytical methods and to import and modify existing methods.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Method Development & Validation

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Quantex Laboratories provides cost effective outsourced cGMP and GLP laboratory services to industry. Analytical methods developed include procedures for active pharmaceutical ingredients (APIs), drug formulations, cosmetics, personal care producuts, and raw materials.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Virtual Booth Quinta-Analytica, a leading Central European one-stop-shop CRO located in Czech Republic. Providing end-to-end solution to its partners

Nordic Life Science Days

Isolation of Selected Components

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We use either a classical low-pressure column chromatography or HPLC on our automated semi-preparative modular HPLC system (Waters).

- Directory Listing

Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Impurity Isolation and Identification

Virtual Booth 100% Export Oriented R&D Center & cGMP facility// Broad range of advance fine chemical intermediates & APIs

Pharma ChemOutsourcing

Impurity Profile Studies

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- Service Details

State-of-the-art R&D center is located in our Ankleshwar facility. Highly qualified professionals with the scientific bent of mind are working in product development, analytical development and intellectual property rights.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Impurity Isolation and Identification

Virtual Booth A partner for the pharma and biotech industries to improve patient outcomes & quality of life

CPhI Worldwide

Booth No. 80K30

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Method Development & Validation

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AMRI's laboratory team has extensive experience in designing and executing protocols for method development and validation, method verification and method transfer.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Virtual Booth USFDA, EDQM, ANSM, KFDA, TGA Inspected// in 60 countries // Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl

CPhI Worldwide

Booth No. 40K20

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Impurity Isolation and Identification

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Malladi’s Research & Development is well-equipped with a wide range of process & analytical capabilities such as structure elucidation, impurity identification & profiling, method & specification development for API and stability stabilities.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Impurity Isolation and Identification

Analytical Method Development & Validation

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Our contract services group helps companies turn their new drug ideas into reality. Whether for phase I, phase II, phase III, or toxicology studies, we specialize in developing new synthetic routes while providing all necessary support to ensure regulatory compliance.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Virtual Booth Offering Full Spectrum of services from early stage of synthesizing potential NCE's to Large-Scale Commercial Operation.

CPhI Worldwide

Booth No. 40C20

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Identification of Impurities

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ScinoPharm's comprehensive analytical services include purity testing, characterization of polymorphs, analytic methods development and validation, as well as stability testing. All analytical instruments and data are managed through the company's Laboratory Information Management System

- Directory Listing

Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Impurity Isolation and Identification

Virtual Booth Unither Pharmaceuticals, a world-leading pharmaceutical contract development manufacturing organization (CDMO)

Contract & Outsourcing Conference

Method Validation

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- Service Details

Unither can provide provide standalone pharmaceutical R&D services such as analytical methods validation, ICH stability studies, clinical batch manufacture, and clinical primary packaging.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Virtual Booth Energise your science for life

Process Optimization FDA Audited

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Dishman's analytical services support both process control and material characterisation for laboratory and production chemistry from initial raw material release to release of the final APIs.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Gel Permeation Chromatography for Impurities

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CARBOGEN AMCIS state-of-the-art infrastructure includes process research and development (PR&D) laboratories, one laboratory dedicated to conjugation of small and large molecules and manufacturing capabilities.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Impurity Isolation and Identification

Optimization, Modernization & Validation of M...

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Galien LPS offers analytical services which covers: Stability studies ICH and On-going; Analyses of raw materials and finished products; Optimization and modernization of methods , HPLC to UPLC transposition ; Validation; Reports, trend analysis.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Analytical Method Development & Validation

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Our integrated product development services help biopharmaceutical companies shorten time to market, manage risk and access new global markets to maximize portfolio value.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Impurities and Related Substances

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Arbro offers pharmaceutical testing and research services to support the development, approval, and manufacture of pharmaceutical raw materials and finished products. Arbro is listed on a number of leading pharmaceutical manufacturer’s licenses as the contract analytical testing site.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Impurity Isolation and Identification

Analytical methods development

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Uetikon offers an extensive expertise to its pharmaceutical and biotechnology partners.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Analytical Method Development & Validation

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With Admix Pharma Laboratories, LLC you will enjoy a host of attractive benefits that can effectively extend your in-house pharmaceutical products development and manufacturing capabilities for long and short term projects.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Impurities Assay

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Acceleration Laboratory Services is the foremost Contract Solutions Provider for the pharmaceutical research. The ultimate goal for our associates is to deliver superior solutions to our clients, on time, and on point, while maintaining a fun and empowering work environment.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Impurity Isolation and Identification

Virtual Booth Quinta-Analytica, a leading Central European one-stop-shop CRO located in Czech Republic. Providing end-to-end solution to its partners

Nordic Life Science Days

Capillary Electrophoresis Analytical Method D...

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Quinta-Analytica is a capillary electrophoresis service provider it operates in full compliance with GCP/GLP/GMP and FDA standards. Quinta offers capillary electrophoresis analytical method development services and capillary electrophoresis method development for pharmacopoeial drugs.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Capillary Electrophoresis

Virtual Booth A partner for the pharma and biotech industries to improve patient outcomes & quality of life

CPhI Worldwide

Booth No. 80K30

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Screening of Chiral Stationary Phases & Metho...

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AMRI provides HPLC screening of chiral stationary phases from diverse manufacturers to ensure the achievement of appropriate selectivity and quantitation limit. AMRI also offers chiral SFC method development as a complement to chiral HPLC.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Chiral HPLC & SFC Method Development

Analytical Development

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Crenza is a full scale R&D centre for development of Parenteral and Ophthalmic drug products. Crenza is founded by Industry professionals with invaluable experience and proven track record of development and commercialization of Parenteral and Ophthalmic drug products for regulated markets.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Overview

Chiral Separation

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Primera specializes in customized analytical method development, transfer and validation using state-of-the-art analytical tools. We also provide cGMP Sample Storage and testing services. With no observations and no 483 findings from two FDA audits, We are in full compliance with GLP/cGMP regulations.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Chiral HPLC & SFC Method Development

BioReliance® Validation Services

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Accelerate and simplify your path to market by letting our BioReliance® Validation Services help you select, test and validate the filters, assemblies and single-use systems for drug manufacturing processing.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Formulation Validation Support Testing

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Our product analytics division offers full analytical testing services to ensure your products and ingredients comply with regulatory requirements for quality and purity.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Virtual Booth Quinta-Analytica, a leading Central European one-stop-shop CRO located in Czech Republic. Providing end-to-end solution to its partners

Nordic Life Science Days

LC / MS & GC / MS Methods for Trace Analysis

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We are skilled in the development of analytical methods for determination of trace amounts of tracked impurities. For our customers we usually develop methods for assessment of toxic impurities at levels much below those demanded by corresponding regulatory authorities.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Impurity Isolation and Identification

Analytical Method Development & Validations

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PSR has necessary expertise & access to advanced technologies to develop the formulation and also, through the use of targeted analytics, supply the client with the relevant information needed to aid in the correct selection of formulation/drug delivery system to meet the clients requirements.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

CCIT Method Development & Validation

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- Service Details

Crenza is a full scale R&D centre for development of Parenteral and Ophthalmic drug products. Crenza is founded by Industry professionals with invaluable experience and proven track record of development and commercialization of Parenteral and Ophthalmic drug products for regulated markets.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Biopharmaceutical Analytical Development

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Our 1,700 square meter development laboratories and pilot plants are active in: Protein purification.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Analytical Development & Validation

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- Service Details

Our experienced team are here to deliver your custom small molecule API development projects on time, within budget and to the highest quality standards.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

ICH Q2 (R1) & cGMP Compliant Method Developme...

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Tepnel performs analytical method development and validation in accordance with the ICH Q2 (R1) guidance and cGMP for both small and large molecules.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Drug Substance Impurity Profiles

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- Service Details

Primera specializes in customized analytical method development, transfer and validation using state-of-the-art analytical tools. We also provide cGMP Sample Storage and testing services. With no observations and no 483 findings from two FDA audits, We are in full compliance with GLP/cGMP regulations.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Impurity Isolation and Identification

Virtual Booth Quinta-Analytica, a leading Central European one-stop-shop CRO located in Czech Republic. Providing end-to-end solution to its partners

Nordic Life Science Days

Analytical Method Development

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- Service Details

Methods transfers are performed according to the GMP procedures and approved method transfer protocols. Similarly, method validations are also strictly performed according to the GMP procedures and approved validation protocols.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Overview

Reference Standard Qualification

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- Service Details

Acceleration Laboratory Services is the foremost Contract Solutions Provider for the pharmaceutical research. The ultimate goal for our associates is to deliver superior solutions to our clients, on time, and on point, while maintaining a fun and empowering work environment.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Reference Substances / Qualification

Analytical Method Development & Validation

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- Service Details

SUSHEN Medicamentos (SUSHEN), is a global company of end-to-end pharmaceutical services with focus on drug delivery research and product development. SUSHEN’s expertise can bring a complex formulation project in to clinical and bioequivalence with superior quality, innovative solution.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Impurity Profiling Methods

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- Service Details

Our laboratories, equipped with the most modern instrumentation is operated by a well trained and highly motivated staff with an average of over 10 years of practical experience. The Pharmaceutical Analytical Laboratory is GMP inspected and under control of the respective authorities.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Impurity Isolation and Identification

Identification of Impurities with LC-MS (Q-TO...

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- Service Details

Our skilled and competent Chemistry group uses a wide range of methods to test raw materials, FDFs and packaging components in accordance with compendial procedures including but not limited to: USP/NF, BP, Ph. Eur, JP, CP, FCC, ACS, AOAC, AOCS, In-house and client supplied methods.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Impurity Isolation and Identification

Methods Development & Methods Validation

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- Service Details

Ash Stevens has a dedicated and experienced analytical department providing comprehensive support from early-stage development to commercial API manufacturing.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Assay & Purity Testing of products

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- Service Details

Our testing services are performed using USP/EP guidelines in compliance with FDA and DEA guidelines. Our laboratory is continually updated with new equipment to adapt to changing regulations and the ongoing needs of our clients.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Impurity Isolation and Identification

Purity Testing

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- Service Details

UPM’s analytical group has a diverse background in analytical method development and in-depth understanding of all facets of the drug development process.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Impurity Isolation and Identification

Reference Standard Characterization

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- Service Details

Our laboratories, equipped with the most modern instrumentation is operated by a well trained and highly motivated staff with an average of over 10 years of practical experience. The Pharmaceutical Analytical Laboratory is GMP inspected and under control of the respective authorities.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Reference Substances / Qualification

Chiral Method Development

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- Service Details

We undertake development of critical parameters or methods, such as analytical method to determine impurities, which don't have chromophores and hence don't have detection, Chiral method development, LC-MS suitable method development.

- Directory Listing

Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Chiral HPLC & SFC Method Development

Analytical Method Validations

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- Service Details

Stability studies & Analytical Method Validations & Process Validation Scale-up batch production.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

cGMP Method Validation & Development

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- Service Details

ACTA performs cGMP method validation in accordance with USP and ICH requirements. Parameters normally validated are accuracy, precision, specificity, limit of detection, limit of quantitation, linearity, range and robustness. ACTA’s staff is highly experienced with method development for

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Analytical Method Development & Validation

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CLEARSYNTH team has extensive experience in developing, optimizing and validating methods. Our reliable analytical methods and techniques ensure that the quality of the products that we have produced is of the highest standards.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Pharmaceutical Method Development and Validat...

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Our laboratory has 25 years of in depth experience with designing and executing method development and validation, verification and method transfer protocols and experiments.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Design and Validation of Analytical Method

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The R&D Department is staffed with fully trained and highly experienced scientists and has at its disposal state-of-the-art facilities striving to produce products according to GMP/GLP global standards.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Development & Validation of Analytical Method...

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Our researchers executes every phase of the development process with the utmost care, including identification of reliable suppliers of active ingredients, realization of laboratory and industrial-scale trial batches, development and validation of analytical methods and stability studies.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Full Impurity & Polymorph Control

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Fermion R&D has over 40 years API development experience. Tacit knowledge is combined into an efficient, standardized development scheme saving time and costs.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Impurity Isolation and Identification

Impurities / Related Compounds

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Our testing services are performed using USP/EP guidelines in compliance with FDA and DEA guidelines. Our laboratory is continually updated with new equipment to adapt to changing regulations and the ongoing needs of our clients.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Impurity Isolation and Identification

Development & Validation of Analytical Method...

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Menadiona's services also can include development and validation of analytical methods, filing of drug master files and regulatory support.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Analytical Development, Validation & Transfer

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We offer full service solutions and project management for cost effective product development in pharmaceutical as well as food /nutraceutical areas.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Development & Validation of Diffusion Profile...

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By Complying major guidelines and pharmacopeias (ICH, EMA, FDA, USP, EP), Our mission is to develop and validate reliable methods analytical methods for drug substances, excipients, drug products, raw materials and cleaning methods and diffusion profiles adapted to formulation.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Analytical Development & Validation

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Servier CDMO offers a full range of contract development and manufacturing services, from concept and product development to analytical testing, commercial scale and regulatory approval.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Impurity synthesis, Isolation and characteriz...

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Our integrated product development services help biopharmaceutical companies shorten time to market, manage risk and access new global markets to maximize portfolio value.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Impurity Isolation and Identification

Identification & Qualification of Impurities ...

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Quantex Laboratories offers comprehensive impurities testing for both small and large molecule drug products and medical devices.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Impurity Isolation and Identification

Impurity Isolation & Identification (Includin...

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Ash Stevens has a dedicated and experienced analytical department providing comprehensive support from early-stage development to commercial API manufacturing.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Impurity Isolation and Identification

Validation of Product Manufacturing Process

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cGMP-conform micronization means having a valid process. We are pleased to offer this service by means of the validation of the product manufacturing process.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Analytical Capabilities- Methods Validation &...

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Orit Laboratories comprises of analytical testing laboratories and formulation development areas operating under cGLP and cGMP. Orit has a number of products already approved and marketed, with several additional products already filed and under FDA review.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Analytical Method Development & Validation

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KriSan Biotech offers world class services of new drug process and analytical R&D for small molecules and peptides from Pre-clinical (IND) to Phase II.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Qualification of API Impurity Profile

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GRAM Laboratories provides services geared towards qualification of an active pharmaceutical ingredient, through monograph testing, compendial and vendor method verification, qualification of impurity profile, independent verification of vendor’s certificate of analysis.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Impurity Isolation and Identification

Analytical Method Development & Qualification

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Equipped with the advanced instruments HPLC, GC-HS, Particle size analyzer, UV, IR, Digital polarimeter, Multinuclear NMR (400MHz), we are expert in various techniques, for instance, Chiral chemistry (Classical racemate resolution, Resolution by entrainment), Second-order asymmetric transformation..

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Overview

Analytical Method Development

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Full method development and optimization based on client’s specific needs such as TCID50, qPCR, FACS, HCDNA/HCP determination, osmolality, pH conductivity, microscopy.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Overview

Validation & Analysis

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Fermion R&D has over 40 years API development experience. Tacit knowledge is combined into an efficient, standardized development scheme saving time and costs.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Impurity Tracking & Characterization

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Servier CDMO offers a full range of contract development and manufacturing services, from concept and product development to analytical testing, commercial scale and regulatory approval.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Impurity Isolation and Identification

Analytical Method Development

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Our in-house laboratory, Diteba, offers analytical services in:Method development, validation and method transfer for Potency assay, Related substances (impurities), Dissolution methods; Forced degradation studies; and Cleaning validation testing.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Overview

Impurity Profiling

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Sequent Research is a leading Contract Research Organization that specializes in Analytical and Bio Analytical Services to support the API, Pharmaceutical, Personal Care, Institutional and Nutraceutical companies.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Impurity Isolation and Identification

Reference Standard Qualification

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KriSan Biotech offers world class services of new drug process and analytical R&D for small molecules and peptides from Pre-clinical (IND) to Phase II.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Reference Substances / Qualification

Isolation & Characterization of Impurities

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Clearsynth team has extensive experience in developing, optimizing and validating methods. Our reliable analytical methods and techniques ensure that the quality of the products that we have produced is of the highest standards.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Impurity Isolation and Identification

Development of Analytical Methods for Subsequ...

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Design of a novel synthetic pathway accompanied by supply of a few grams, provision of pilot batches following development of the industrial procedure and GMP production of several tons of product along with regulatory file drafting.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

GMP and ICH compliant Method Development & Va...

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GMP and ICH compliant analytical equipment enabling our teams to perform simple ID testing and analytical method transfers, through method development and validation, to EU product release and ICH stability testing, ensuring data reliability and regulatory compliance.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Overview

Resolution of Chiral Compounds

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Clearsynth team has extensive experience in developing, optimizing and validating methods. Our reliable analytical methods and techniques ensure that the quality of the products that we have produced is of the highest standards.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Preparative Resolution Processes

Method Development, Validation & Transfers

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Our cross functional teams at Etico namely are Business Development, Formulation Development, Analytical Development, Development Quality Assurance, Microbiology, Project Management, Regulatory Affairs, IPR management, HR, Finance & IT.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Impurities Testing

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R.D. Laboratories maintains a large array of analytical instrumentation capable of performing a wide variety of procedures.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Impurity Isolation and Identification

Reference Standards

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We have a large number of Anaytical Reference Standards available in stock for delivery

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Reference Substances / Qualification

Develops, Validates & Transfers New Methods o...

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The quality of API manufactured by Arevipharma has sealed their good reputation among customers. Raw materials, intermediates, API and primary packaging are checked in accordance to specification and communicated and professionally documentated in an efficient manner.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

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Analytical Method Development & Validation

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Our finished dosage form development team has successfully created numerous control release and extended release formulations, successfully ensuring afterward rapid scale up to full production.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Analytical Method Development

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We undertake complete analytical project development activities for formulation as well as API products. This includes analytical method development for RMs, Intermediates, Inprocess and finished product in line with regulatory requirements.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Overview

Identification of Pharmaceutical Impurities

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Servier brings 60 years of experience in process development, intermediates, APIs and high-potency APIs. Our full cGMP?/?FDA-approved chemistry network includes R&D, production and supply chain expertise with full regulatory support.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Impurity Isolation and Identification

Development & Validation of Analytical Method...

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Our services include the development & validation of analytical methods. We identify by-products and determine polymorphic product forms's broad portfolio of analytical methods includes HPLC(-MS), CE, GC(-MS), FT-IR, NMR, particle size determination etc.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Overview

Process Validation & Validation of Analytical...

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Legacy Pharmaceutical supports you with process development, process validation & validation of analytical methods, commercial production, & sales of your products. Perfect planning and sustainable documentation result in successful product transfer.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation

Reference standard qualification and maintena...

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Ash Stevens has a dedicated and experienced analytical department providing comprehensive support from early-stage development to commercial API manufacturing.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Reference Substances / Qualification

Analytical Development

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Flagship biotech had established A state-of-art Research and Development Centre (R&D) at Mumbai - focused towards developing new products, improving existing products as well as drug delivery systems and expanding product applications.

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Pharma Service: Analytical

Category: Analytical Method Development

Sub Category: Method Development and Validation