Pharma Regulatory Services

Pharma Regulatory Services
Product Description

- Pre- and Post- Authorization Consultancy - Marketing Authorization Applications (NAP/DCP/MRP) - Life Cycle Management (renewals, variations etc.) - Submission of regulatory – related documents to Health Authorities - e-CTD submissions

Read more Show less

Sustchem S.A.

  • GR
  • 2022
    On CPHI since
View company profile
Categories
more categories Show less

Sustchem S.A.

  • GR
  • 2022
    On CPHI since
View company profile

More Products from Sustchem S.A. (2)

  • Medical devices - Regulatory Services

    Product Medical devices - Regulatory Services

    - MDR &IVDR CE certification - Data Gap analysis - Technical Documentation - Clinical & Biological evaluation - Risk management (ISO 14971) - Performance evaluation - PMS Plan & Report, PMCF Plan & Report, PSUR, PMPF - Vigilance - EUDAMED - National registration services - Economic operators’ com...
  • Medical Writing & Toxicological Reports

    Product Medical Writing & Toxicological Reports

    - PDE - OEL - Clinical and non-clinical overviews - Environmental Risk Assessment

Sustchem S.A. resources (1)