Global Compliance Panal
GMP Expectations for Products Used in Early Phase IND Studies
Global CompliancePanel Webinar Areas Covered in the Session: * Discussion of the elements found in the guidance document for Phase 1 material. * What to do at really early stages. * What about special IND studies? * What about preclinical studies? * Varying GMP activities that depend upon the nature of the IND product. * What are the requirements for the GMP found in the Food, Drug, and Cosmetic Act? * What to do about QC activities such as instrument qualification, method validation, and process validation.
API Importation Panel
Discussion on the reform in FDA inspection of offshore pharmaceutical/API manufacturing.
Dionex ICS-5000 Chromatography
The ICS-5000 Reagent-Free IC (RFIC) system with Eluent Generation is the world’s first capillary IC system. Developed with flexibility,…
cGMP Manufacturing, Drug
Development and Specialty Chemicals
Particle Sciences, Inc.
Drug Development Services
Nanosystems, Formulation, Analytic
Hovione - API Manufacture
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pharmaceutical fine chemicals.
Pharma Outsourcing Trends
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Pharmaceutical Outsourcing Industry
Specialists in high performance
Raman Spectroscopy instrumentation