How can JensonR+ help you?
All medicinal products need to obtain a marketing authorisation (MA) before they can be placed on the market. The MA certifies the product meets the required standards of safety, quality and efficacy.
There are four routes to gaining a MA in the EU:
Centralised Procedure (CP)
Mutual Recognition Procedure (MRP)
Decentralised Procedure (DCP)
With experience across all four routes, JensonR+ provides regulatory support and guidance throughout the application’s lifespan. We can compile and submit dossiers in eCTD format and support you getting your product to market as efficiently as possible. We then work hard to ensure it stays there.
We can create full eCTDs for new applications as well as convert dossiers in part or whole for older MA applications and variations. We also have extensive experience in Post Marketing Maintenance, maintaining your product by conducting licence transfers, variations, renewal applications, reclassification of medicines and Periodic Safety Update Reports (PSURs) to ensure that your product continues to meet the necessary standards of safety, efficacy and quality.
JensonR+ can act as applicant for your procedure in the UK or Europe as we have offices in both the UK and the EU. JensonR+ is also an SME company so can benefit from fee reductions and deferrals.