Navigating the regulatory landscape.
Aptiv Solutions has significant experience in helping clients understand the regulatory requirements for the development of medicinal products and medical devices covering everything from strategic development planning to market registration.
Our regulatory consulting services team will provide representation in front of Regulatory Agencies, author regulatory documents, and manage the submission process to regulatory approval:
Regulatory Consulting Services Expertise:
- Regulatory strategy and agency advice covering EU, US & Japan
- Regulatory document authorship
- Specific expertise in working with the regulatory guidelines for Adaptive Clinical Trials
- Legal representation for drug, biologic & device trials
- E-publishing & e-submissions, including complete documentation management for IND/CTA, Drug Master Files, Marketing Authorizations (NDAs, BLAs, MAAs), PIPs and Orphan Drug Applications
