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:
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
Med-Tech Innovation Expo 2023
The JensonR+ team are looking forward to attending Med-Tech Innovation Expo 2023 – the UK and Ireland's leading event for medical device manufacturing.
Expansion of services
In March, JensonR+ and regenold joined forces to shape our future together. We are delighted to announce that we are delivering on that commitment with the appointment of our new Regulatory Manager, Tom Wood who will lead the JensonR+ Medical Devices team.
Medicinal product clinical trials review
In 2022 the UK government consulted on planned revisions to the regulatory environment for medicinal product clinical trials, focusing on a more streamlined regulatory regime whilst still protecting the interests of patients. The consultation results have been published, and the resulting proposals will be taken forwards into legislation.
Are your promotional materials compliant
Brought to you in partnership with Medilink Midlands, JensonR+ Director James Hall along with Senior Regulatory Officer Mihai Inceu, are to host a free-to-attend webinar that will highlight the importance of ensuring your promotional materials are compliant with industry codes and adhere to legal guidelines.