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
Medilink Innovation Day 2023
Our Associate Director, Regulatory Janet Worrell will be accompanied by some of the JensonR+ Regulatory team at the Medilink Innovation Day on Thursday 5th October at DoubleTree by Hilton in Coventry.
Regulatory Rabbit Hole
Tom Wood navigates through a regulatory rabbit hole - a series of searches through standards and regulations in search of a definitive answer to a very specific question. Each step leads to another cryptic reference and a reference to another piece of legislation or MDCG document.
Codeine linctus from P to POM
The Medicines and Healthcare products Regulatory Agency (MHRA) has released a consultation on the potential reclassification of codeine linctus to a prescription-only medicine.
Congratulations Sue Lakeman
Congratulations to Sue Lakeman on 10 years service at JensonR+. Sue is one of our longest-serving team members, joining the company in July 2013.