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
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Pharmaceutical Solutions for Product Development
From compounds to commercial production, we are the pharmaceutical product manufacturing partner you can rely on. Discover why Vici is the best CDMO for pharma production. Speak with one of our experts about your project today.