ClinChoice’s exceptional medical writers combine their expertise in medicine, science, and technical writing to deliver concise documents for regulatory submissions.
Consumer Health
Post-Marketing Services
ClinChoice conducts a review of post-market data extracted from the global safety database, as well as literature research and reviews to author reports to meet post-marketing requirements. ClinChoice also specializes in authoring and submitting specialized reports in response to ad hoc requests from health authorities. Our proficiency extends to overseeing contributions from diverse stakeholders, conducting meticulous multi-level reviews, and addressing multi-region requirements within a consolidated report. This streamlined approach alleviates the complexities associated with managing multiple aggregate reporting obligations, ensuring efficiency and compliance in reporting processes.
- PBRERs, PSURs, and PADERs
- RMP and REMS
- Canadian aggregate reports
- Addendum reports
- Addendum to clinical overview
- Ad hoc BR evaluation reports and other ad hoc safety reports
- Responses to regulatory authority queries