The staff at Summit has extensive experience in the regulatory aspects of product development for traditional and recombinant drugs, biological therapeutics, vaccines, and gene therapies. Regulatory services encompass regulatory strategy and planning, including Target Product Profiles, FDA liaison, meeting preparation, and the drafting and submission of regulatory documents, including pre-IND packages, INDs, Requests for Orphan Drug Designation, and other applications to FDA and other regulatory authorities. Summit also has taken the lead for its clients in preparing Appendix M submissions for the National Institutes of Health (NIH) Office of Biotechnology Activities (OBA) in its evaluation of new gene therapy proposals.  Summit staff become an important part of the regulatory team in preparing for and participating in FDA meetings and in defending the clients' submissions to FDA reviewers.

Summit has frequent and direct interaction with FDA’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) across numerous review divisions. Summit customizes its regulatory services to the client's needs, focusing on the most efficient and cost effective strategies for gaining regulatory support and maximizing the likelihood of timely product approval.  Summit welcomes the opportunity to assist your organization in providing a full development package or in preparing discrete regulatory documents. The high quality of our documents and our excellent relationships with FDA officials reflect our extensive FDA and regulatory experience.

Regulatory Services include:

• Development of regulatory strategies for IND and NDA/BLA
• Drafting target product profiles to facilitate FDA communication
• Organization and submission of pre-IND Information Packages, INDs, NDA/BLA/CTD, ANDA and other regulatory submissions
• Preparation for and participation in key FDA Meetings (e.g., Pre-IND, End of Phase 2, Pre-NDA)
• Interface with FDA and other regulatory authorities as primary regulatory representative or as supporting team members
• Preparation and submission of specialized regulatory documents including Request for Orphan Drug Designation, Appendix M, and Special Protocol Assessments
• IND Maintenance (preparation of IND Annual Reports, IND Amendments, IND Safety Reporting)
• Regulatory due diligence for product acquisitions and mergers
• Post marketing promotional materials review and submission
• Regulatory advice on intellectual property protection, product extensions