Regulatory Submission Management
Aptiv Solutions has expertise and experience in the authorship, preparation and management all types of regulatory documentation associated with product development, regulatory approval and maintenance. The regulatory submission management team utilizes an advanced and widely accepted submission management system (docuBridge®) to streamline the regulatory submission process.
Regulatory Submission Management Expertise:
- Full IND/CTA service including Adaptive Clinical Trials
- Drug Master Files
- Pediatric Investigational Plans
- Orphan Drug Applications
- Marketing Authorizations (NDAs, BLAs, MAAs)
- Established drugs: 505(b)2s, “Hybrids”, ANDAs, Generics• Risk Management Plans
- IDEs/PMAs
- CE Marks
