Post-Approval Regulatory Management
Post-approval and Life Cycle Regulatory Management
The regulatory group at Vici Health Sciences provides a variety of post approval regulatory services. Call us today to find out why our clients trust their drug development projects with our regulatory services, from development to post-approval regulatory compliance.
- CBE-0 (Changes Being Affected in 0 days)
- CBE-30 (Changes Being Effected in 30 days)
- PAS (Prior Approval Supplement) - Preparing and submitting documentation for post-approval changes to the drug product, ranging from minor to major change
- Annual Report: Compiling and submitting annual reports summarizing changes and updates to the approved NDA or ANDA
- Preparation and Review of Gap Assessments - Conducting Gap Assessments for Global Product Adaptation to the US Market
- Annual/Quarterly PADER Submission: Periodic Adverse Drug Experience Report (PADER): Preparing and submitting reports that summarize adverse drug experiences, ensuring ongoing safety monitoring of the marketed product
- Submission of Annual Reports to Approved IND/NDA: Prepare and submit annual reports to the FDA, summarizing the status of the drug, including clinical study updates, manufacturing changes, and new safety information
- Patent listing in the Orange Book
- Deferral extension request for PMR studies