Feasibilty and Stability for APIs and other drug products

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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

Stability testing is a fundamental part of any product regulatory submission. Stability data will be required on both the drug substance (API) and the formulation(s). The Guidance documents from ICH (International Conference on the Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) have standardized the data requirements in the three ICH regions (Europe, Japan and the United States); however, the different details can be daunting to the uninitiated.

FinnBrit Consulting can advise on all aspects of stability testing programs for both APIs and drug products.

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