Medicinal Products 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

Medicinal finished products are intended for administration to patients for the treatment amelioration of disease (similarly for veterinary finished products and the treatment of animals). For smaller companies, particularly those companies using contract manufacturing, it is important to assess and monitor the quality systems at the contract site.

In addition it may be necessary to transfer manufacture of a product from one facility to another, e.g., during the transfer from clinical trials manufacture to commercial manufacture. Site transfer requires attention to detail to ensure that the necessary documentation and records are created and maintained and the final project reports prepared and authorized. For such projects it is advisable for the contractee to have access to the necessary understanding and expertise.

FinnBrit Consulting can assist in both the assessment of routine manufacturing and in technical transfer and validation.

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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