NDA CMC Documentation for Drug Development

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 NDA is one of the most important documents in the life cycle of a drug development project. A well written and presented NDA can facilitate the timely approval of the application; however, a poorly written and presented NDA can cause delays, and delays are expensive. The Chemistry, Manufacturing and Controls (CMC) Section of the NDA must now be compiled according to the format specified in the ICH Common Technical Document (CTD).

FinnBrit Consulting can advise clients on all NDA CMC (CTD) issues.

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