Regulatory

Our regulatory strategy professionals can guide you through the planning and execution of your Target Product Profile (TPP). Tactical plans will be developed to enhance value, whether your plans include an expedited development and review program, proof of concept (POC) licensing transaction, orphan indication application, or registration in multiple regions.

Technical development and review of your regulatory filings will ensure accuracy and a consistent message. Our regulatory affairs consultants can work with your team to develop phase-appropriate, clear, and concise documents to support both domestic and global submissions.

Our regulatory operations professionals can assist you with selection of an appropriate electronic vendor to allow for quick and efficient submission of your documents to regulatory agencies. We can also provide training in the use of document templates and formatting, manage the submission review process, and provide lifecycle management for your regulatory filings. By acting as the liaison with your chosen electronic vendor, we can also reduce the costs associated with document quality control (QC), and will provide a review of the filing against current industry guidance.