How can the JensonR+ Regulatory Consultancy team help you with your Regulatory Affairs?
Our Regulatory Consultancy team are experienced and knowledgeable and offer comprehensive support in developing your regulatory affairs strategy.
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. From preparing the dossier, publishing in the right format and managing the procedure from submission to close-out;our experts can also assist you with the preparation of responses to questions raised by [MHRA] or EU regulatory agencies. Once registration is complete, JensonR+ can support you with ongoing maintenance for the registration dossier.
Our Regulatory Consultancy team can also review existing dossiers for gaps and regulatory compliance.
Our expertise extends from Medicines and Medical Devices to Food Supplements and Cosmetics.