The Regulatory Affairs department is an important part of any pharmaceutical company. It is the interface between the company and the regulatory authorities which assess the efficacy and safety of medicines and grant marketing authorisations (the right for a company to sell a medicine in that country or group of countries).
The Regulatory Affairs department keeps abreast of the legislation and guidelines set by regulators and works with colleagues in research and development to ensure that studies and trials that are required by regulatory authorities before a marketing authorisation application is submitted are performed. Once the studies and trials are completed the Regulatory Affairs department compiles the data into dossiers for submission regulatory authorities.
The Regulatory Affairs department also works with clinicians to prepare the prescribing information for doctors and other healthcare professional prescribers, the labelling and the patient Information leaflet that is used once the medicine is marketed.
Compliance to regulatory and marketing authorisation requirements is key for every pharmaceutical company including Thame. The Thame Laboratories Regulatory Affairs department ensures that Purchasing, Manufacturing and Quality departments work in full compliance with authorisations .Back