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Analytical testing is a critical part in every step of drug development and manufacturing. The qualitative and quantitative results generated from validated analytical testing provide first-hand information to control and ensure the quality and safety of raw materials, intermediates, and finished products. Like many other CMC (chemical, manufacturing and control) activities, analytical testing is also frequently outsourced. Many factors are attributed to this rapid market growth, including continuous outsourcing from pharmaceutical companies, growing pipelines for biological candidates, and increasing demand for more analytical details on drugs and process development by regulatory agencies. In response to the changing market dynamics, service providers are striving to provide analytical testing with quality, accuracy, and robustness all within tight timelines. As the contract research organizations (CROs) have become more integrated, small analytical labs need to establish their niche to succeed. Global contract anlytical Laboratories provide QC laboratory analysis, method development, validation and expert advice for both finished products and raw materials for pharmaceutical and biopharmaceutical companies. Recently, the International Conference on Harmonisation (ICH) regulatory guideline QIA was revised (R2) when QIF “Stability Data Package for Registration Applications in Climatic Zones III and IV” was incorporated. The main changes included: Adjustment of intermediate storage conditions (previously 30°C ± 2°/60% RH ± 5%); acceptable relative humidity was changed to 65% ± 5% for drug substances, drug products and drug products packaged in semi-permeable containers, 30°C ± 2°/65% RH ± 5% can be used for long-term storage instead of 25°C ± 2°/60% RH ± 5% for drug substances and products, 30°C ± 2°/35% RH ± 5% can be used for long-term storage instead of 25°C ± 2°/40% RH ± 5% for drug products packaged in semi-permeable containers. Stability testing is required for all biopharmaceutical drug products to detect all changes in identity, purity, and potency as a result of a number of environmental and processing factors. Whether testing is conducted in-house or through contact laboratories, it involves the development and performance of comprehensive and specific stability protocols for all stages of a product’s life cycle. Testing product stability in-house requires significant time and resources, and carries challenges associated with commercialization market, time, and capacity. Stability assay methods should be specific enough to differentiate between analytes and possible degradation products. The overall quality of drug-substance and drug-product batches placed on formal stability studies should represent the quality of materials used in clinical studies and of the quality of materials to be made at manufacturing scale. Supporting stability data can be provided using stability data generated from batches of drug substances and drug products made on a laboratory scale. Stability studies also should be conducted on material stored in a container–closure system that is the same as (or simulates) packaging proposed for real storage and distribution. GMP Stability Services include cGMP registration stability programs, Design, storage and management, Development and validation of stability indicating methods, Stability testing for APIs, Clinical Trial Materials, formulated products, Tailored reporting (timepoint and final reports), All ICH conditions storage, Photostability (ICH Q1B Options 1 & 2), Temperature cycling, freeze-thaw and shipping studies, Bespoke or specialised conditions,Stability contingency and disaster recovery storage etc. Depending upon the aim and steps followed, stability testing procedures have been categorized into the following four types: Real-Time stability testing, Accelerated stability testing, Retained sample stability testing and Retained sample stability testing. Stability Studies are performed to understand the compounds/formulation in development: Physical & Chemical properties of API and drug product, Drug and excipient compatibility, Impact of manufacturing process steps, Interactions with packaging materials, Assignment of shelf life etc.

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APC Ltd

AlbyPharma

Ash Stevens, Inc.

Biovian

Boston Analytical

Cambrex Corporation

Cebiphar

Chromcore Lifesciences

Curida AS

Dannalab B.V

Delorbis Pharmaceuticals LTD

GRAM Laboratory Inc

LabConnect

Lamda Laboratories

Merck Millipore

Nanjing Dorra Pharmaceutical Technology Co.,Ltd

Nutrasource

Nuvisan GmbH

PHYTOPHARM KLEKA S.A

Polfa Tarchomin S.A

Progenerics Pharma Pvt Ltd

Proveris Scientific

QUINTA-ANALYTICA s.r.o

Quotient Sciences

Recro

Ropack Inc

Shijiazhuang Rainbowlabs Pharmaceutical Technology Co.Ltd

Tepnel Pharma Services

Unique Biotech Limited

mKnal Global Solutions

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Virtual BoothLeaders in Spray & Aerosol Product Testing and Contract Services.

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Proveris Scientific Corporation delivers innovative testing platforms, laboratory services, and deep product knowledge to customers who develop, manufacture or test orally inhaled and nasal drug products (OINDPs).

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Pharma Service: Analytical

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Virtual BoothTransforming Drug Development with Science & Innovation.

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Quotient has extensive analytical experience in testing drug products including preclinical prototype evaluation, excipient compatibility, finished product purity testing, physical characterization & ICH stability testing of drug products.

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Virtual BoothExperts in Development and Manufacturing Solutions for Oral Solid Dosage Forms

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Recro provides various analytical testing services including raw material, in-process & finished product release testing, physicochemical characterization, method development & validation (assay, impurities, dissolution, cleaning), etc.

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Virtual BoothGlobal provider of comprehensive top services in the field of Drug Testing, Clinical Trials & Bioanalytical Services.

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Manufacturing validation of the finished dosage form is the one of the most important processes in the GMP production. Manufacturing process has to be validated under GMP.

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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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Shijiazhuang Rainbowlabs Pharmaceutical Technology Co. Ltd (Rainbowlabs) is a FDA-inspected laboratory set up to provide high quality laboratory testing and services to pharmaceutical companies throughout the world.

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Shijiazhuang Rainbowlabs pharmaceutical Technology Co. Ltd (Rainbowlabs) is a FDA-inspected laboratory set up to provide high quality laboratory testing and services to pharmaceutical companies throughout the world.

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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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At Nutrasource, we offer a variety of testing services to provide your firm with the necessary qualifications for a CoA for your product.

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Shijiazhuang Rainbowlabs pharmaceutical Technology Co. Ltd (Rainbowlabs) is a FDA-inspected laboratory set up to provide high quality laboratory testing and services to pharmaceutical companies throughout the world.

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Tepnel offers a comprehensive raw material testing, pharmacopoeial testing and microbiology testing of pharmaceutical excipients and ingredients service. Our raw material testing supports formulation development within research and development, release of excipients and APIs.

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A highly experienced lead Project Manager (PM) will be assigned to lead your study. Your PM will serve as your primary contact and will be responsible for the execution of all laboratory related aspects of your trial.

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Shijiazhuang Rainbowlabs pharmaceutical Technology Co. Ltd (Rainbowlabs) is a FDA-inspected laboratory set up to provide high quality laboratory testing and services to pharmaceutical companies throughout the world.

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UBL offers private labeling services enabling you save years of research and development activities before you enter the market.

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An advantage of this method is that it permits the observation of objects that have not been stained or fixed, showing them in their native aqueous environment (in contrast to X-ray crystallography, which generally requires placing the samples in non-physiological environments).

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Shijiazhuang Rainbowlabs pharmaceutical Technology Co. Ltd (Rainbowlabs) is a FDA-inspected laboratory set up to provide high quality laboratory testing and services to pharmaceutical companies throughout the world.

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As a leader life science industry, Merck’s new technologies and workflow solutions enable life science researchers in pharmaceuticals, biotechnology, and academia to engage in critical research.

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Shijiazhuang Rainbowlabs pharmaceutical Technology Co. Ltd (Rainbowlabs) is a FDA-inspected laboratory set up to provide high quality laboratory testing and services to pharmaceutical companies throughout the world.

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