Regulatory services

regulatory services

Medical Need can as a service for our partners provide European regulatory assistance and advice in managing Marketing Authorization Applications, variations and maintenance both on an EU and national level in European countries.

We also hold experience from and can provide assistance to Orphan Drug Designations (ODD), Pediatric Investigation Plans (PIP) and strategic regulatory planning. Through a European network we can assist Partners in market access activities, including pricing and reimbursement, to secure the availability of pharmaceuticals to the health care system and patients in different countries.

We can assist Partners in Quality Assurance issues such as Standard Operation Procedures (SOPs) and Quality and Pharmacovigilance agreements.