Regulatory Affairs Services

We combine our depth and breadth of knowledge with a passion for healthcare, giving our clients tailored solutions and an integrated, seamless service.

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Regulatory Strategy

Regulatory Strategy

After the expenditure and effort of product development, it is essential to ensure that you get the best out of your investment. Our experts will guide your regulatory strategy to help you get the most from your products in the best possible timeframe.

We can advise you during your development process, evaluate the risk-benefit profile, ensure the generation of the best data for your registration filing, and work with you to develop the optimal regulatory strategy to fit your requirements on timing, budget and markets of interest.

eCTD, Dossiers, Technical Files

We can advise you during your development process, so you generate the best data for your registration filing. We will work with you or your manufacturer to prepare your full registration dossier or technical file in accordance with legislative requirements and guidance.
We can review existing dossiers for gaps and regulatory compliance, or simply publish your dossier in the right format.

We can also manage the regulatory 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.

Where there is a need, we can act as the Marketing Authorisation holder in the European Union.

Scientific Advice Meetings

Early dialogue with the regulatory authorities provides direction for your development activities and helps to ensure you produce the right evidence to support your registration. It is an important method to start building a successful relationship between your company and the regulatory agency.

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.

Scientific Advice Meetings

Due Diligence/Gap Analysis

For greater reassurance during acquisitions and in-licensing activities, our team of experienced specialists will review individual product data, registration dossiers or entire portfolios to identify and address technical data gaps, ensure compliance with current legislative standards, and identify areas of concern.

We can also help to bring your dossiers up-to-date in preparation for out licensing activities.

Clinical Trials Applications

We can co-ordinate, prepare, review and publish all parts of the CTA dossier, and manage the regulatory procedure from submission to close-out. We can also support ongoing maintenance activities to ensure the CTA dossier remains up to date, including end of trial notifications upon study completion.

For sponsors based outside the European Union, we can act as your legal representative in the European Union.

Change in Legal Status (Switch)

Change in Legal Status (Switch)

Our regulatory specialists can assist with changes in legal status for your prescription medicine portfolio. Our review service will evaluate your portfolio to identify suitable candidates for ‘switch’ activities. 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 strategy. We will also prepare the registration package and manage the regulatory process.

Master Files

Our technical team can help you with the preparation or evaluation of Site Master Files, Pharmacovigilance System Master Files and Active Substance Master Files, and guide you through the various registration processes associated with these different types of master file.

Fast Track

JensonR+ was one of the first companies to implement an expedited approval process in conjunction with the UK Department of Health. We can evaluate your proposed registration for fast-track suitability, and develop the justification.

Variations/Renewals

We can help you to maintain regulatory compliance for your licences, whilst maximising opportunities and reducing timeframes and costs through a well-considered regulatory strategy. We can prepare the dossier, manage the procedure and advise on change control.

Artwork & Readability

Artwork & Readability

Ensure the message is getting through to patients using our readability testing and evaluation service. We can produce and assess original product artworks and manage the relationships between our clients, printers and production teams.

SME Applications

Did you know that smaller companies may benefit from discounts or delayed payment terms from regulatory agencies? JensonR+ can assist with your application for Small-Medium Enterprise (SME) eligibility, to make sure you don’t miss out.

Risk Management Plans

We can help you to identify, evaluate and address risks, and we’re are experienced in the creation and implementation of risk management plans. We can also help you to prepare risk reduction materials aimed at patients and healthcare professionals, and assist you to gain approvals for risk reduction materials with individual regulatory agencies.