How can JensonR+ help you?
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 are at the forefront of the marketing authorisation process. We can prepare the dossier, publish in the right format and manage the procedure from submission to close-out and our experts can assist you with the preparation of responses to questions raised by the regulatory agency. Once registration is complete, we can support you with ongoing maintenance for the registration dossier. We can also review existing dossiers for gaps and regulatory compliance.
Our expertise extends from Medicines and Medical Devices, to Food Supplements and Cosmetics.
We can provide the following services:
eCTD publishing
Dossier module writing
Dossier gap analysis
Scientific advice meetings
Scientific Advice Meetings with regulatory agencies can be very useful. Our team can guide you through the entire process, from making the meeting arrangements and preparing the list of questions with briefing information, through to chairing your meeting and formalising the outcome.
Rx to OTC switches
Our regulatory specialists can assist with changes in legal status for your prescription medicine portfolio. Our experts will liaise with relevant regulatory authorities, healthcare professional and consumer-patient organisations to determine current opinion and assist in the development of the regulatory affairs strategy. We will also prepare the registration package and manage the regulatory process.
Product lifecycle management
Talk directly to one of our experienced team
Janet Worrell
Head of Regulatory
Ben Smith
Regulatory Affairs Officer
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 Affairs Team
Regulatory Submissions
A regulatory submission is the process through which your company provides information to the regulatory authorities for review, whether this is for a new product you want to launch or for maintenance of an existing one.
Regulatory Strategy
The development of your regulatory strategy, aligned to your commercial strategy, is the principle activity you need to establish to deliver the business goals for your company. It is the glue that binds together development, commercial and regulatory aspiration.
CAP Grandfathering Update
The Regulatory team at JensonR+ have been reviewing the changes in MHRA guidance on this topic since the end of the UK-EU transition period. They have captured the key changes and actions that need to be taken in a helpful video
Reclassifying Medicines
JensonR+ Regulatory Affairs Officer Natasha Barrow looks at what medicine reclassification is , why it happens and what makes for a successful reclassification.
We would like to talk to you and we will listen.
We aim to understand your objectives, your aspirations and your ultimate goals.