Pepgra provides Medical Writing Solutions for Regulatory Affairs to a wide range of people and organization. The regulatory team at Pepgra is led by professionals with over 15 years of experience in clinical research, product development, data standards, quality assurance, and regulatory affairs. Our mission is to provide our clients with unmatched expertise, collaborative efficiency, unprecedented quality registration documents and primary manuscripts.
For Global Regulatory Affairs:
1. Develop regulatory strategies for preclinical through Phase IV programs
2. Pre-IND, end of Phase I/II and pre-NDA briefing packages
3. Pre-investigational device exemption (IDE) briefing packages
4. Investigational new drug applications
5. Investigational device exemptions application
6. New drug applications
7. Investigational NDAs
8. Supplemental NDAs
9. Abbreviated NDAs
10. BLAs
11. Premarket notification applications (510(k))
12. Premarket approval applications (PMA)
13. Investigational medicinal product dossiers (IMPD-EU)
14. Clinical trial applications (CTA-HC)
15. Perform QA Audits, due diligence reviews, data verification, and development program evaluations
16. Clinical trial authorizations (IND, CTA)
17. Prepare for meetings with authorities; Briefing Packages/Regulatory Response Documents
18. Interpret ICH, FDA and EMA regulations and guidance
19. Prepare SmPCs, IMPDs, BLAs, ANDAs, NDAs, INDs Summary submission documents (e.g. Clinical Summaries of Safety and Efficacy, Guidance to Investigators)
20. We also prepare Annual periodic safety reports – INDARs, PADERs, CRSURs, PDURs.
21. Develop Post-marketing Study Final Reports, Correspondence, and Distribution Reports
22. Prepare for Electronic Regulatory Submission and Review (ERSR)
Contact Address:
IND:+91 8754446690
US:+1-972-502-9262
UK:+44-1143520021