L O A D I N G

REGULATORY SERVICE AND PHARMACOVIGILANCE

Our company is made up of a dynamic team specialized in regulatory affairs service, who have acquired an outstanding reputation with customers and partners over the past tenth years. We collaborate to compile registration dossiers to obtain marketing authorizations in the most efficient way, based on all applicable laws, regulations, and instructions of the pharmaceutical regulatory framework in place.

Over 10 years’ of experience in

  • Complete assessment of registration dossiers
  • Drugs regulatory strategy on accelerated & national registrations procedure
  • Medical Devices registration procedures
  • Food Supplements, Nutraceuticals & Cosmetics handling, based on local

WINPHARMA’s expertise in Regulatory Services includes:

Registration phase with the Health Authorities

  • Coordination/preparation of module 1 documents (administrative phase)
  • Coordination of translation activities (Patient Information Leaflet)
  • Gathering of quality documentation (GMP certificates)
  • Preparation of cover letters and electronic Application Forms
  • Marketing Authorization Submission:
  • National procedure hard and soft submission
  • Accelerated procedure hard and soft submission
  • Follow-up and communication with the Health Authorities during the evaluation phase
  • Answers to Health Authorities’ questions