Clinical Trial Supplies and Quality Assurance

Publications Presentations

Patent Preparation Expert Witness

New Product Acquisition Drug Delivery Systems

Preformulation Formulation and Process Design Analytical Method Development and Validation Feasibility and Stability Quality By Design IND CMC Documentation Bioavailability Reverse Engineering of Pharmaceucial Formulation

Quality By Design Process Optimization Scale-Up and Clinical Manufacture Analytical Methods Regulatory Stability Process Validation Technical Transfer Bioequivalence Testing NDA CMC Documentation

Quality By Design for Excipients Excipient Safety Regulatory Alternate Sources Quality Management Systems

Excipients Drug Delivery Systems Clinical Trial Supplies Medicinal Products

The expectation from the regulatory agencies (and volunteers and patients) is that all medicinal products intended for human (or veterinary) use will be manufactured to the level cGMP commensurate with the stage of clinical development.

In addition, scale-up will be inevitably part of any successful clinical development project. The correct integration of clinical trials supplies manufacture and scale-up can save both time and resources.

FinnBrit Consulting can advise clients on the appropriate level of GMP for the provision of clinical trials supplies including integration of scale-up.

All information published throughout www.finnbrit.com is intended for information only, and does not contain any warranties, implied or otherwise.

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