Submissions

PPD provides preparation of 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 your project team, PPD assists you in effectively meeting your objectives and successfully maintaining your application.

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 provides preparation of all major regulatory submissions globally, including quality control review. We also conduct critical appraisal and gap analysis of your submission 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 the United States, the United Kingdom, Belgium, Germany, Spain and Canada, 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.

Therapeutic Expertise:

PPD offers expertise in the following therapeutic areas and product types:

• Anesthetic, critical care and scheduled/controlled drugs
• Anti-inflammatory, analgesic and ophthalmic
• Antiviral
• Biologics
• Biotechnology products
• Cardio-renal
• Dermatologic and dental
• Gastrointestinal and coagulation
• Gene therapy products
• Medical imaging, radiopharmaceutical
• Metabolic and endocrine
• Neurology
• Psychiatry
• Oncology
• Over-the-counter
• Pulmonary