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
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.
UK Reliance Procedure
On 24th January 2023, the MHRA announced that further to the recent extension of the European Commission Decision Reliance Procedure (ECDRP) route to 31 December 2023 , from 1stJanuary 2024 there will be a new international recognition framework in place to replace it.
A career in pharma
How did some of our team find their way to working at JensonR+ and how do they feel about their chosen career? We've been asking the questions and to kick things off, let's hear from Karen Bradshaw in our Regulatory team.
Women’s Health – A Holistic Approach – Review
World Menopause Day saw JensonR+ partnered with Medilink Midlands for our Food Supplements Special Interest Group. This in-person event was dedicated to how nutrition and supplementation can impact women’s health.