Regulatory Affairs

Regulatory Affairs

We offer a full range of regulatory affairs consultancy services within the EU. Medical writing, CMC & Manufacturing, Registration strategy, Regulatory compliance and more.

We provide both off-site and on-site support. The company employees manage projects for a variety of clients ranging from large multinational pharmaceutical organisations to SMEs taking innovate products to the EU market.

We also have a network of flexible regulatory consultants covering same range of activities in other countries of central and east Europe.

1. Medical writing

  • Dossier preparation (writing modules 2, 4 & 5 for original, generics, WEU, hybrid, THMP applications)
  • Periodic Safety Update Report (PSUR) writing
  • Summary of Product Characteristics (SmPC)
  • Patient Information Leaflet (PIL)
  • Direct Healthcare Professional Communication, DHPC

2. CMC & Manufacturing

  • Dossier preparation – modules 2&3 (registration, variations, renewals)
  • Expert reports – ERA, PDE etc.
  • Contract QP
  • GMP audit

3. Regulatory affairs

  • Registration strategy
  • Regulatory compliance – Gap analyses/Due Diligence Reports
  • MA applications and submissions (DCP, MRP and NP) preparation
  • Communication with competent authorities
  • Life-cycle management (variations, renewals, line extensions, annual reporting) eCTD/NeeS publishing » Our services » Regulatory Affairs