Regulatory Affairs

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Regulatory Affairs

We provide wide range of Regulatory Affairs services:

Tailor-fit regulatory strategies

  • Due Diligence for Licensing
  • Gap Analysis
  • Audits of dossier documentation (Module 3, ASMF review)
  • Advice on the legal basis of your application, and support documentation (modules 1.5, 1.7, 1.9)
  • Advice on specific requirements: generics, hybrids, WEU, traditional herbal medicinal products
  • Scientific advice to support switch of classification for supply
  • Strategies for borderline products
  • Feasibility and Risk Assessment of your applications
  • Project Management
  • Liason with regulatory authorities

Marketing Authorisation Applications

  • Full management of MAAs
  • EU procedures: MRP, DCP, National procedures
  • Representation in national step (DCP/MRP), transfers of MAH
  • Service as MAH, including a fully compliant Pharmacovigilance System
  • Full dossier compilation
  • eCTD submissions, dossier conversion into eCTD
  • Registration outside the EU, access to the South American market

Post-authorisation services

  • Advice on applicable variations and preparation of support documentation
  • Renewals, Licenses, fast track applications, transfers, and others
Let Altiex Life assist you in maintaining your regulatory compliance to achieve your projects.
Registered Office
  • Nám. 14. října 2/1307
  • 150 00  Praha 5 
    Czech Republic
  • Tel: +420 222 351 874
  • Fax: +420 222 351 875