Global Regulatory Affairs

The marketing authorisation procedures of medicinal products are among the costliest and most time-consuming in the world. The necessary documents are subject to special requirements. mt-g is very well acquainted with all the different regulators' and statutory specifications of the relevant global regulatory procedures. The goal of our Global Regulatory Affairs project management team is to provide pharmaceutical companies and manufacturers of medicinal products with high-quality translations that take account of such specifications and are strictly on schedule.
  • Covid-19 texts and documents

    • Translation and adaptation/updating of product information texts with known active substances and their potential use in Covid-19
    • New marketing authorisations for new active substances following completion of clinical trials and proof of efficacy in the treatment of Covid-19
  • Product information

    • Summary of Product Characteristics (SmPC)
    • Labelling
    • Package information leaflet (PIL)
    • QRD templates incl. annexes
    • QRD convention
    • EDQM standard terms
    • Swissmedic templates
    • BfArM templates
    • Compliance check
    • Number check
    • EMA PDF user guide and checklist
  • Other authorisation-relevant information

    • Documentation of medicinal product safety (pharmacovigilance)
    • eCTD components (Modules 1-5)
    • GMP, GLP and GCP guidelines
    • SOPs
    • Authorisation process correspondence
  • Regulatory Affairs

    • Centralised procedure (CP)
    • Decentralised procedure (DCP)
    • Mutual recognition procedure (MRP)
    • National procedure (NP)
    • Pre-submission support
    • Post-submission support
    • Pre- and post-opinion support
    • Linguistic review
    • Variations
    • Line extensions
    • Renewals
  • Pre- and post-authorisation support services

    • Regulatory quality assurance in the translation process
    • Preparation of patient-friendly PIL texts
    • Support during the linguistic review
    • Software-assisted quality reviews
    • Readability studies and bridging
Your contact
Christoph Buchfelder
Team Leader Global Regulatory Affairs
Unsere Qualitätsstandards sind durch die tiefe Spezialisierung und
fortwährende Prozessoptimierung auf einem außergewöhnlich hohen Niveau.