Loading...

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:

  • Regulatory strategy

  • Regulatory submissions

  • 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

  • Achieving Small Medium Enterprises (SME) status

READ A CASE STUDY

Talk directly to one of our experienced team

Janet Worrell
Head of Regulatory
Ben Smith
Regulatory Affairs Officer
Medilinkem

The team at Medilink EM have worked closely with Janet Worrell and the team at Jenson R+. 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.

Costa Philippou, Medilink EM

Read the latest updates from our Regulatory Affairs Team

We would like to talk to you and we will listen.

CONTACT US

We aim to understand your objectives, your aspirations and your ultimate goals.

2021-02-24T10:15:40+00:00