Regulatory Submissions
PPD helps clients meet regulatory objectives and maintain applications successfully. Our extensive experience preparing all major regulatory submissions for Phase II-IIIb clinical trials, including complex multinational submissions, covers quality control review of each submission for verification of compliance with applicable guidelines. We also review submissions for potential refusal-to-file issues.
In addition, we conduct critical appraisal and gap analysis, a technique for determining what useful information is missing in a submission and suggesting solutions for solving the problem of our clients' submissions. Electronic submission services are available in addition to traditional paper document services.
Our experience in regulatory document and submission production includes:
- 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)
Global Reach and Regulatory 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.
