Regulatory Affairs
Throughout the drug development process, the Regulatory Affairs team ensures that the data and documentation collected is sufficient to support the drug’s registration by various health authorities worldwide.
Our Regulatory Affairs team analyses and compiles documentation from the clinical and non-clinical studies, quality data and the manufacturing process. This documentation is submitted to the regulatory authorities for assessment.
The role of Regulatory Affairs continues after the launch of a new product as further approval is required for all new developments to the drug, for example:
- Changes in the manufacturing process
- New indications
- New pharmaceutical formulations
- Additional safety information that requires changes in the labelling
- New markets and requirements from regulatory authorities.
Pharmacovigilance/Patient safety
Throughout the life cycle of LEO Pharma products, we continuously provide up-to-date information regarding benefits and risks of our products, based on information from many sources including preclinical and clinical trials, case reports from healthcare professionals, people being treated with our medications, literature and quality assessments.
