Regulatory Submissions
The Regulatory Affairs experts and scientific associates at PharmaDirections can assist in the preparation and submission of your complete IND. We offer individual experts or a team who can individually or collectively provide these services:
- Pre-IND Meeting and Briefing Book
- Determine objectives and specific questions
- Prepare draft meeting request
- Finalize and submit meeting request
- Follow up with FDA regarding meeting date and advise team
- Develop investigational plan and study design/prepare first draft protocol synopsis
- Finalize investigational plan/protocol synopsis and signoff (deliverable to Regulatory)
- Prepare Pre-IND Briefing Book Sections
- CMC Summary
- Pharmacology Summary
- Toxicology Summary
- Clinical Summary
- Investigational Plan/Protocol Synopsis
- Finalize briefing document
- Submit briefing document to FDA
- Prepare client for Pre-IND Meeting with FDA
- Participate in meeting with FDA
- Prepare meeting minutes
- Submit meeting minutes to FDA
- Author original IND documents
- Author amendments/supplements
- Author Annual Reports
- Prepare or review documents for submission
- Submit documents to Regulatory Agencies