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
Navigating the Sunset Clause
As we approach the 3-year milestone since the conversion of EU Centrally Authorised Products (CAPs) into PLGB MAs (Marketing Authorisations) via the grandfathering process on January 1st, 2021, it is crucial for Marketing Authorisation Holders (MAHs) to be well-informed about the upcoming "sunset clause." This clause is scheduled to come into effect on December 31st, 2023, with significant implications for these MAs.
International Recognition Procedure Guidance
The MHRA hosted a webinar relating to the International Recognition Procedure (IRP) on Thursday 14th September. This webinar expanded on the MHRA guidance published on 30th August. This post captures the key findings from both the webinar and guidance page to help clients who are considering utilising this procedure to make informed choices.
Launching NexTec Medical UK
We are excited to announce the launch of the new Nextec Medical UK website. Nextec Medical is a part of the Jenson Group of companies and offers UKRP services, post market surveillance and vigilance services for medical devices and in vitro diagnostics in the UK. With over a decade of experience in medicines and medical device consultancy we are your trusted partner for market access in the UK.
International Recognition Procedure
From 1st January 2024, the MHRA will be introducing new International Recognition Procedures (IRP) for marketing authorisations in the UK for both new and generic medicines. These recognition procedures will absorb the existing EU recognition procedures; the EC Decision Reliance Procedure (ECDRP) and the Mutual Recognition/Decentralised Reliance Procedure (MRDCRP), as well as introduce new recognition procedures for medicines authorised by the MHRA’s specified Reference Regulators (RR).