Analytical Method Development and Validation

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International manufacturer and supplier

Almac Sciences
… provide method development and validation services for both API and drug products - [e]

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Germany

BioProof AG
Analytical method development and support for formulation development - [e]

CMC Pharma GmbH
Entwicklung, Bewertung und Optimierung analytischer Methoden und ihre Validierung - [d, e]

Currenta
GMP Analytik: Methodenentwicklung und Methodenvalidierung - [d]

GBA
Chemische und mikrobiologische Methodenentwicklung und -validierung nach ICH / VICH Richtlinien - [d]

ICA
… agiert bundesweit auf dem Sektor Chemische Analytik, Methodenentwicklung und -validierung sowie Schulung und Beratung - [d]

Novia
Schnelle Methodenentwicklung in der RP-HPLC - [d, e]

Phytos Labor für Analytik von Arzneimitteln GmbH & Co. KG
Entwicklung und Validierung von neuen Analysenmethoden für pharmazeutische Wirkstoffe und für chemisch definierte Substanzen - [d]

Prolytic GmbH
Bioanalytik: Methodenentwicklung, Validierung nach FDA / EMEA (ICH) - [d, e]

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United States of America, USA

Aptuit Inc.
… provides dedicated services and support to customers for all phases of drug development. All work is performed to cGMP and ICH guidelines - [e]

Boston Analytical Pharmaceutical Services
Method development and Validation per ICH/FDA Guidelines - [e]

DPT Laboratories, Ltd.
… provides comprehensive analytical development and analytical validation services to support drug development projects as well as commercial drug manufacturing - [e]

KBI Biopharma, Inc.
Robust methods for characterization, stability and release - [e]

Pace Analytical Life Sciences
… has a department of senior level scientists that is dedicated to performing method development and ICH method validation services - [e]

PTRL West, Inc
Analytical method development and validation - [e]

Quantex Laboratories
… provides comprehensive analytical method development and method validation services - [e]

Scynexis Inc.
Analytical method development and validation expertise - [e]

Syngene International Ltd.
Methods development services - [e]

Velesco Pharmaceutical Services
Velesco's experienced analytical staff specializes in analytical method development and validation for early to late stage pharmaceuticals - [e]

West Palm Beach Analytical Development, LLC (WPBAD)
… is an analytical development company that specializes in FDA/ICH compliant analytical method development, method validation, method transfer, deformulation, counterfeit product identification, analytical chemistry consultative services, and analytical chemistry training at your site - [e]

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United Kingdom

Kuecept Ltd
Assay / related substance method development and validation - [e]

Onyx Scientific Limited
… has extensive experience in analytical method development and validation. All validations are carried out to ICH guidelines which include the generation of validation protocols outlining the tests to be performed, analytical methodology, validation solution preparation and acceptance criteria all prior to initiating the validation study - [e]

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European Union

ChtomSword - Latvia
HPLV method development solutions - [e]

Corden PharmaChem - Ireland
Analytical development - [e]

PTRL Europe
Analytical method development and validation - [e]

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Canada

Exova
Pharmaceutical analytical method development and validation - [e]

Other notes:

Related Books and Scientific Literature: Analytical Method Development:

Werner Funk, Vera Dammann, Gerhild Donnevert, Sarah Iannelli

Quality Assurance in Analytical Chemistry:
Applications in Environmental, Food and Materials Analysis, Biotechnology, and Medical Engineering.

This best-selling title both in German and English is now enhanced by a new chapter on the important topical subject of measurement uncertainty, plus a CD-ROM with interactive examples in the form of Excel-spreadsheets. These allow readers to gain an even better comprehension of the statistical procedures for quality assurance while also incorporating their own data. Following an introduction, the text goes on to elucidate the 4-phase model of analytical quality assurance: establishing a new analytical process, preparative quality assurance, routine quality assurance and external analytical quality assurance. Besides updating the relevant references, the authors took great care to incorporate the latest international standards in the field.

Wiley-VCH; 2007