How can JensonR+ help you with Regulatory Affairs?
The field of regulatory affairs encompasses all the work that is necessary to receive and maintain a marketing authorisation or registration for a medicinal product. After the expenditure and effort of product development, it is essential to ensure that you get the best out of your investment.
Dossiers are at the forefront of the marketing authorisation process. We can prepare the dossier, publish in the right format and manage the procedure from submission to close-out and our experts can assist you with the preparation of responses to questions raised by the regulatory agency. Once registration is complete, we can support you with ongoing maintenance for the registration dossier. We can also review existing dossiers for gaps and regulatory compliance.
Our expertise extends from Medicines and Medical Devices, to Food Supplements and Cosmetics.