Regulatory services

Regulatory services


  • MAA
  • Dosier Preparation
  • eCTD Publishing
  • Procedure Management
  • National Procedure
  • Decentralised Procedure
  • Centralised procedure

Post Approval:

  • Variations / Renewals
  • MA transfer

Our services are equipped to handle unique regulation challenges in the pharmaceutical industry, from New Product Support to Life Cycle Management. We manage regulatory needs throughout the pharmaceutical industry.

Regulatory Strategy

We work with clients on the strategic planning of regulatory submissions with US and European Authorities.

Regulatory Intelligence

We track regulatory changes around the globe and provides updates applicable to MAHs products. We do it weekly, monthly and 6 monthly updates. We also reconcile our updates with the MAH.

Product Labelling

We can prepare and submit updates to the Summary of Product Characteristics (SmPC), patient information leaflets, and product labelling based on the product post-authorisation use.

Responses to Health Authorities

We help MAHs in responding to RA queries. Particularly related to product safety and PSUR assessment report.


We provide submission services to regulators and Competent Authorities worldwide, electronically wherever possible, through hosted production and document management systems

+44 7769 029865

Don't Wait

Call Now
parallax background

Check, how we can help you!

Have a question?
Write to us!