Regulatory Submissions
PPD has extensive experience preparing all major regulatory submissions, including complex multinational submissions. Our regulatory project management oversight covers quality control review of each submission for verification of compliance with applicable guidelines and for potential refusal-to-file issues. As part of our client's project team, PPD helps it meet objectives and successfully maintain applications.
PPD has extensive experience in all areas of document production for:
- Abbreviated new drug applications (ANDA)
- Biologics license applications (BLA)
- Clinical trial authorization/application/exemptions (CTA/CTX)
- Clinical trial notifications (CTN)
- Common technical document (CTD)
- Drug master files (DMF)
- Fast track applications
- Investigational drug exemptions (IDE)
- Investigational new drug applications (IND)
- Marketing authorization applications (MAA)
- New drug applications (NDA)
- New drug submissions (NDS)
- Orphan drug applications (ODA)
- Premarket approvals (PMA)/510(k)s
Submission Expertise and Support
PPD prepares all major regulatory submissions globally, including quality control review. We also conduct critical appraisal and gap analysis of our clients' submissions and offer solutions early in the development process. Electronic submission services are available in addition to traditional paper document services.
Global Reach and Understanding
With offices in North America, Europe, Latin America and Asia, PPD's global regulatory affairs team is an experienced, diplomatic and effective liaison with all major multinational regulatory authorities and skilled in the coordination and preparation of complex multinational regulatory submissions.
