Regulatory Affairs
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
- info@altiex.com
