Regulatory Operations
At IMPACT, we can take care of all your regulatory operations needs throughout your program development. IMPACT’s regulatory affairs professionals are well-equipped to handle your regulatory submissions, maintain your IND, and assist with any regulatory agency meetings. For smaller organizations, we often serve as a virtual regulatory department, providing expertise as required while allowing our clients to avoid the expense of full-time staff. We have developed a strong understanding of the reviewing practices and regulatory submission requirements with the FDA and regularly represent our clients at critical agency meetings.
IND Submissions and IND Maintenance
We have extensive experience preparing entire FDA IND submissions or components of INDs across a variety of therapeutic fields. In addition, IMPACT’s regulatory affairs professionals can handle all your IND maintenance needs.
Our functions include, for example:
- Authoring, compiling, and submitting the IND
- Serving as a client’s Authorized US Representative with FDA
- Preparing all types of IND Amendments, such as Protocol Amendments, Information Amendments, Responses to FDA requests for information, Annual Reports and Expedited Safety Reports
Regulatory Agency Meetings
Meeting with the FDA or other regulatory agencies is a vital component to a successful drug development program and requires deliberate strategy and preparation. IMPACT’s regulatory affairs consultants routinely assist clients with regulatory agency meetings. Our services include such activities as providing regulatory strategy, authoring the briefing package, preparing for and participating in the meeting, serving as the client’s representative, writing meeting minutes and providing any follow-up documentation following the meeting.
- Regulatory strategy
- Briefing document coordination & preparation
- Logistic support
- Preparation and coaching of your team for the meeting
- Sponsor representation at meetings
- Meeting follow-up, including analysis, meeting minutes, and dispute resolution