Regulatory affairs

Strong regulatory affairs support is crucial

Qplus consult provides expert knowledge on global and local regulatory affairs.

Becoming a Marketing Authorisation Holder (MAH)

There is a large amount of legislation in place to ensure that new medicines are effective and safe to use. In order to gain marketing authorisation for a medicinal product you have to submit numerous documents to the Competent Authorities. This process can have a significant impact on your resources, and approval delays can cost your company a lot of money.

Qplus consult maintains your registration dossier up-to-date

Our experts are qualified to and have a lot of experience in managing your Regulatory Affairs (RA) activities. Even after your products have received marketing authorisation, our RA managers stay active and carefully monitor all changes in regulation, legislation and guidelines in order to keep your dossier up-to-date.

Our areas of expertise include:

Full management of your RA-activities and reporting in name of your organization
Follow-up and full transparency on the product life-cycle status
Prepare, submit and follow-up applications for and variations to Marketing Authorisations through the National, the Mutual Recognition or Decentralised procedure
Create, review or update the quality, clinical and nonclinical sections of dossiers in-line with the latest relevant EU guidelines, Eur. Ph. monographs etc.
Coordination of Packaging materials/Artwork preparation and review, full management and follow-up
Reformat dossiers to the Common Technical Document (CTD) format
Preparing Module 2 of the CTD: clinical and nonclinical summaries and overviews
NeeS submissions
SESSP submissions
Medical writing for RA including: Summary of Product Characteristics, Patient Information Leaflet, Company Core Data Sheet, CTD Module 2: clinical and non-clinical sections, Summary of Clinical Efficacy, Summary of Clinical Safety, Clinical Overview, Periodic Safety Update Report, Narratives, Investigational Medicinal Product Dossier, Clinical Study Report, Briefing document, Risk Management Plan, Pediatric Investigation(al) Plan and Benefit Risk Assessment Report

Need an RA expert? Contact us for a free appointment!

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More and more companies consider Qplus consult as their preferred partner

We are passionate about our business and are always striving for the utmost quality and perfection. Therefore your regulatory affairs projects are researched much more in-depth, which results in a higher quality of the finished project and an adequate detection of possible errors in existing documents and procedures. Contact us now to find out how they can assist you.