Strategic & Regulatory Development Guidance
This expert service offering typically includes the development of a carefully designed regulatory plan (clinical, nonclinical, CMC and procedural activities) that must be accomplished to meet a specific corporate goal for a company’s product. Developing sound, right-sized development plans is at the foundation of all of Facet’s service offerings. We understand that there are hundreds of possible approaches to product development. Some may guarantee an FDA approval, but at a cost and/or under timelines that are untenable for a small company.
At Facet, our expert regulatory strategists bring additional value to our customers through business experiences that have regulatory impact but are not considered to be traditional regulatory activities. For example, many of our leaders have been involved in product acquisitions and divestitures, due diligence, corporate mergers, and government policy discussions. We have worked as a partner to other groups to advise and ensure that these business activities were successful. We draw on both our business and regulatory experiences to add value to our customers in everything we do.
Our guidance is tailored to your product, your specific company goals, your financial and market considerations, and your risk tolerance. We provide suggestions on how to “push the regulatory envelope” and whenever possible, have recommended faster and/or more cost-effective plans for development that have proven successful.