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
Cosmetic Product Regulation
The European Commission has launched a public consultation to seek feedback from all interested parties on the upcoming revision of the Cosmetic Product Regulation (EC) No. 1223/2009, and they would like to hear your views.
Supply of Medicines into Northern Ireland – new guidance part 3
Recording of a webinar that our Regulatory team delivered to colleagues in the international regulatory network regulanet®, in which they discussed Medicines Supply to Northern Ireland and the changes in MHRA guidance on this topic.
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Supply of Medicines into Northern Ireland – new guidance part 2
Following our previous post summarising the MHRA Medicines Supply to Northern Ireland Webinar, the JensonR+ team share a brief overview of the Northern Ireland MHRA Authorised Route (NIMAR).
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We aim to understand your objectives, your aspirations and your ultimate goals.