FinnBrit Consulting advises on drug formulation, excipients and provides experiences expert witness

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

Pharmaceutical products have complex and extended development cycles with an absolute minimum of at least five years for a new innovator product, and more than 3 years for a generic drug. Every extra day prior to launch costs money!

FinnBrit Consulting has the necessary experience to guide you through your drug development program beginning with preformulation and their subsequent process design, development and manufacturing to the eventual launch of the finished medicinal product.

Drug formulation has traditionally been considered the Cinderella of drug development. There are numerous pitfalls that must be avoided. The formulation must be stable, since a future stability problem results not only, in an additional cost for a new formulation, but also the cost of the delayed launch of the product. Development projects have failed because of an inability to provide a stable, effective drug product.

An inadequate patent may result in a future loss of an infringement suit against a competitor. An inadequate understanding of the regulatory framework may lead to additional delays because of the need to answer supplementary questions from the regulatory agency and/or provide additional data.

In the same way that formulation is the Cinderella of drug development; excipients are the Cinderellas of formulation design. They do not treat any disease, but without them we cannot provide a formulation for any drug. Excipients are at the core of formulation design, and formulation scientists need to understand them very well. Poor understanding of the advantages and limitations of excipients can lead to poor formulations and costly delays.

In some cases you may be able to eventually save a failed project through additional costly trials or tests. However, the better the initial understanding of the integrated process of drug development, the less costly it will be.

FinnBrit Consulting provides timely advice on all aspects of drug development and excipients that reduce time lines and prevents pitfalls. Always remember that each extra day prior to launch costs money!

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

Site Map