Regulatory affairs

  • Preparation and submission of tender files to the relevant authorities
  • Management of registration files:
  • • Drafting of marketing authorization applications (all modules) in centralized, decentralized and mutual recognition procedures
    • Maintenance of marketing authorization files: Conversion into CTD / eCTD formats, variations, renewal
    • Submission and response to questions from health authorities

  • Management of pharmaceutical documentation – active ingredients/finished products:
  • • Drafting and updating of module 3
    • Drafting of Active Substance Master File (ASMF) variation files, certificate of suitability (CEP)
    • Drafting of Quality Overall Summary (QOS)

  • Strategy/access to market and registration (CE marking) of medical devices.

Biometry

Highly-skilled team dedicated to your projects assuring you on fast and quality work. Our most experienced Data Managers, Programmers and [...]

Clinical operations & development

AIXIAL offers pharmaceutical, biotech and medtech companies full coverage of Phase I-III and late phase clinical studies for drugs and [...]

Vigilance & medical information

AIXIAL offers pharmaceutical, biotechnology, medical device, nutritional and cosmetics companies full coverage for post-marketing vigilance and product safety in Phase [...]

Quality assurance

Audits (investigator sites, CROs, PV System audit) Quality control of documents submitted to relevant authorities Drafting and revision of procedures [...]