Other Sectors
ClinChoice has product safety writers with diverse post-marketing surveillance experience. Our authors use the best industry practices and quality checklists to analyze small and large datasets to develop high-quality reports that comply with health authority regulations. Our services are provided using delivery models that allow our clients to scale their operations to meet planned and unplanned regulatory commitments from health authorities.
Post-Marketing Services
ClinChoice specializes in extracting and analyzing post-market data from designated sources and performing literature reviews to prepare aggregate safety reports for marketed cosmetic products. Our medical writing teams develop medical safety assessments to support product releases, ad hoc safety reports, and benefit-risk evaluation reports.
- PBRERs, PSURs, and PADERs
- RMP and REMS
- Canadian aggregate reports
- Addendum reports
- Addendum to clinical overview
- Ad-hoc BR evaluation reports
- Responses to regulatory authority queries
- Ad-hoc safety reports