Drug Development both for new, novel or generic drugs

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 development of new drug products varies with the type of project. Complexity decreases approximately in following order: new drug candidate, product line extension for an existing prescription franchise, generic version of an existing prescription medicine, Over-the-Counter (OTC) medicine, nutritional supplement, herbal product, etc.

The development of drug products for new drug candidates involves many disciplines over many years. More importantly, the work will be scrutinized by the regulatory agencies. It is therefore important to ensure that the work is carried out properly by competent people in a coordinated manner to deliver reliable results on time. There are many things that can go wrong in such a complex undertaking. Delays that will impact project progress may also occur and will have direct financial implications. Good planning and coordination are essential for any project.

Although perhaps not so complex as the development of a new drug, the other types of project nevertheless require to be undertaken in a professional manner. There are many things that can go wrong and delays will be expensive; e.g. missed filing dates, missed launch dates, etc.

FinnBrit Consulting has the experience and access to experience to provide clients with advice on how to manage and coordinate their drug development projects. FinnBrit Consulting can also assist in project and document review to help clients prepare for filings with the regulatory agencies, or in preparation for licensing and acquisition negotiations.

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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