Regulatory Affairs

Our team of Regulatory Affairs experts plays a pivotal role in your project from initiation to completion, ensuring compliance with applicable laws and regulations throughout the process.

• Extensive Expertise. Most of our Regulatory Affairs team have a PhD and a medical or scientific background and everyone receives ongoing training. Our expertise transcends the realm of standard pharmaceuticals to also include registration for drugs, biologics, and biosimilar products, as well as medical devices.
• Quality Commitment. We meticulously review all applications to ensure they have been completed in accordance with regulatory requirements. And because of our vast experience, we’re able to expedite the process without compromising quality.
• Valuable Services. Our value-added services are included with full-service clinical programs, but are also contracted on a standalone basis:
  • Regulatory Consulting
  • Drug Development Strategy
  • Dossier Evaluations and Gap Analyses
  • Dossier Preparation and Submissions (i.e., IND, IMPD, CTA dossiers, NDA, MAA, registration and maintenance dossiers)
  • Dossiers in all required formats (i.e., CTD/eCTD, NeeS, or others)
  • Orphan Drug Applications
  • Paediatric Dossiers (i.e., PIP)
  • Advice meetings with global Regulatory Agencies
  • Approval of essential documents for product release to study site
• Global Focus. We have strong relationships with regulatory agencies around the world, meeting with their representatives frequently. Our regulatory professionals are strategically located around the world with specific experts available in each country.
• Added Value with eCTD.We can compile your next electronic Clinical Trial Application and Marketing Application in eCTD or NeeS format, which creates advantages such as one stop shopping, proactive planning, rapid submissions and a true partnership with you and your product.