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.Strategic and regulatory guidance are critical parts of product development and are 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.
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.