Regulatory Affairs

  • Human and Veterinary Medicinal Products
  • New Applications
  • Variations Type I, Type II
  • Marketing Authorisations
  • WDA, MIA, ManA, MS Submissions
  • Packaging (inc. artwork mock-ups)
  • Renewals, transfer of ownership, sunset clause
  • Mutual Recognition Procedure (MRP) & Decentralised Procedure (DCP) Applications
  • Regulatory strategy and support

QP-Services UK Ltd have 20 years of experience in Regulatory Affairs and we can support you in all your pharmaceutical licensing requirements. We have an experienced and diverse team.

We prepare all types of submissions for both human and veterinary medicinal products. We can help you develop your regulatory strategy for new and existing products to ensure the quickest route to market.

We originate, compile, publish and validate dossiers in the electronic Common Technical Document (eCTD) and Non-eCTD electronic Submission (NeeS/VNeeS) format, as required.

We can take on all your Regulatory Affairs work, or just provide a helping hand as and when needed. We can be a critical friend, to review and provide comment on ideas and documents you have originated, or we can work independently with just minimal input from you.

We have a proven history of working with not only the MHRA in the UK, but also the HPRA in Ireland and Competent Authorities across the EU. We understand how to communicate with assessors; when to push and when to hold back. 

From the experience within our own team we can write, approve and support expert statements for quality, safety and efficacy.

We have proven systems of working to prevent technical validation issues and minimise questions from assessors to ensure your application is approved without delay.

As well as Marketing Authorisations (MA) we can prepare and submit applications for Wholesale Dealers Authorisations (WDA), Manufacturer’s/Importer’s Licences (Human/Veterinary) (MIA and ManA) and Manufacturer’s Specials Licences (MS).

We have MAs in our name, as well as an MIA and ManA, so we understand the compliance and regulatory requirements as a named licence holder.

Contact us to discuss your requirements.