Regulatory Services

Pre-Approval Regulatory Affairs

Marketing Compliance Regulatory affairs Supplements & Food Cosmetics Marketing Authorization Nordic Regulatory Affairs
Commercial expert recruitment team for Pharmaceuticals

Pre-Approval Regulatory Affairs

At PharmaRelations, we support companies in developing robust regulatory strategies to navigate the complex global landscape. Our experts help you engage with regulatory authorities, advance your clinical pipeline, and optimize the value of your assets. By providing strategic guidance throughout the development phases, we help minimize regulatory risks and accelerate your path to market.

CONTACT US
Beatrice Öström and Sponsor oversight expert

Our Services

  • Regulatory strategy
  • Regulatory agency interactions
  • US IND
  • Clinical trial applications (incl. CTIS)
  • US Fast Track/Breakthrough Therapy Designation
  • EU PRIME
  • Paediatric investigational plan (PIP/PSP)
  • Orphan Drug Designation (ODD)
  • Clinical trial strategies and protocols
  • CMC strategy and documents
  • Pre-clinical strategy and documents
  • Regulatory writing and project management
  • Regulatory intelligence

Our Services

Interim Executives Due diligence PharmaRelations Academy Nordic market entry Audits Specialist recruitment Executive search Consulting & outsourcing Interim solutions

Expertise Areas

Pre-Approval Regulatory Affairs Nordic Regulatory Affairs Marketing Authorization Cosmetics Supplements & Food Marketing Compliance Regulatory affairs
Medical Writing Medical Affairs
Data & Technology Digital & Social Media Sales & Marketing
Clinical development Pre-clinical services
Medical Engineering
Market Access
IVDR – In Vitro Diagnostic Regulation MDR – Medical Device Regulation ISO 13485 – Quality Management Systems Medical Device and IVD
Pharmacovigilance Audits and Inspections Local Pharmacovigilance Pharmacovigilance Global Pharmacovigilance and Drug Safety
Quality Assurance
Cookies

This website uses cookiesfor statistics and user experience.

This website uses cookies to improve your user experience, to provide a basis for improvement and further development of the website and to be able to direct more relevant offers to you.

Feel free to read ours privacy policy. If you agree to our use, choose Accept all. If you want to change your choice afterwards, you will find that option at the bottom of the page.