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Complete Pharmacopeial / Compendial Testing

Analytical >> Analytical Testing Services >> Overview

Cebiphar offers analytical testing of raw materials, APIs, excipients and FDFs. Compendial testing (physicochemical & microbiological) is performed in accordance with Eur Ph, USP, JP. New equipment is regularly acquired to meet regulatory requirements and clients’ needs.

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Lab equipment (pH meter, conductivity meter, analytical balances)

Analytical >> Analytical Testing Services >> Overview

Well-equipped laboratories performing comprehensive tests for the finished products, WIP, raw materials, equipment cleaning in compliance to ICH guidelines using Pharmacopoeial methods, In-house test methods and customer's requirements.

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API Analysis

Analytical >> Analytical Testing Services >> Overview

We provide a full custom manufacturing service to customers looking for a flexible and qualified partner able to produce parenterals in accordance with their specifications. We work in strict accordance to the EU GMP, Good Distribution Practices (GDP), and documented Standard Operating Procedures

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Reference Standard Qualification

Analytical >> Analytical Testing Services >> Overview

Cambrex’s analytical services are based on detailed Standard Operating Procedures (SOPs) and stringent quality assurance practices to comply with cGMP standards. Whether your analytical requirements are big or small, let our expertise in research and compliance meet your needs.

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Analytical Testing Services / Overview

Analytical >> Analytical Testing Services >> Overview

Cebiphar offers analytical testing of raw materials, APIs, excipients and FDFs. Testing is performed in accordance with Eur Ph, USP, or client specific methods. We regularly acquire new equipment to meet new regulatory requirements and clients’ needs.

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Advanced Process Analytical Technology (PAT)

Analytical >> Analytical Testing Services >> Overview

Dedicated laboratory and infrastructure addressing the needs of clients with highly potent synthetic molecules including containment solutions for beta-lactams.

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Analytical Methods for In-Process Control

Analytical >> Analytical Testing Services >> Overview

Biovian provides an extensive set of analytical methods for in-process control and end product analysis.

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Project Management

Analytical >> Analytical Testing Services >> Overview

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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Ion Exchange Chromatography

Analytical >> Analytical Testing Services >> Overview

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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Raw Material Testing

Analytical >> Analytical Testing Services >> Overview

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.

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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