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
The State of Herbal Supplements
The Food Supplement industry has experienced a boom within the last couple of years with people paying more attention to their general wellness and a more holistic approach towards health. In this post Senior Regulatory Officer Mihai Inceu looks at the regulatory framework relating to herbal supplements
Food Supplements
The experienced team at JensonR+ can provide provide practical solutions for Health Food and Food Supplements product development and ingredient selection, label presentation, placing on the market, commercial barriers, regulation interpretation or questions regarding the correct product category, including novel status.
Womens Health – a holistic approach
We're looking forward to partnering with Medilink Midlands for our next Food Supplements Special Interest Group which will mark World Menopause Day with an in-person event dedicated to exploring how nutrition and supplementation can positively impact women’s health.
Copy Approval
Our Copy Approval team review of all kinds of promotional materials, from exhibition stands, digital adverts, conference materials, videos, apps, websites, the list goes on...