The Pharma One Company’s Regulatory Affairs Department, in full compliance with applicable law and regulation, provides regulatory services to its partners. The services provided by the Pharma One regulatory department are:
• Registering new products, verifying the application file and following procedures to ensure product approval and market placement.
• Maintenance of current records (renewals and variations).
• Medical device registration.
• Pharmacovigilance. Managing product safety, tracking and collecting and reporting of medicine side effects (ADR) cases as well as medicine related adverse events.
Pharma One provides its partners with up-to-date regulatory information, helping them understand local requirements related to the above regulatory issues.