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
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.
Our Regulatory Consultancy team can provide the following services:
Talk directly to one of our experienced team
Janet Worrell
Head of Regulatory
Ben Smith
Regulatory Manager
The team at Medilink EM have worked closely with Janet Worrell and the team at JensonR+. Through her network, Janet has been able to provide our organisation, over a period of more than 6 years, with a wide variety of expert speakers for a series of successful professionally organised events on food supplements. Largely due to Janet’s initiative and hard work, we have formed a unique networking forum for this sector of the life sciences industry within the East Midlands.
Read the latest updates from our Regulatory Consultancy Team
Nutraceuticals, a new product sector for the UK?
Last month, the Taskforce on Innovation, Growth and Regulatory Reform (TIGRR) report was published, giving its recommendations to the Prime Minister on how the UK can reshape its approach to regulation and seize new opportunities from Brexit.
A Day in the Life of our Graduates
A day in the life of Fran Ward and Natasha Barrow, our Graduate Regulatory Affairs Officers and an insight into starting a career in the midst of a global pandemic
Reclassifying Medicines
JensonR+ Regulatory Affairs Officer Natasha Barrow looks at what medicine reclassification is , why it happens and what makes for a successful reclassification.
Updating the QPPV for the MR/DC procedure
Regulatory Affairs Officer Natasha Barrow takes a look at the current process for managing updates to the summary of the pharmacovigilance system for EU and UK licences approved through the Decentralised/Mutual Recognition procedure.
We would like to talk to you and we will listen.
We aim to understand your objectives, your aspirations and your ultimate goals.