Consulting for Life Sciences - Regulatory Operations

Compilation and publishing electronic submissions

    • Outsourcing submissions is becoming increasingly popular with Pharmaceutical companies of all sizes.
    • We compile
      • eCTD
      • NeeS
      • ACTD  (for ASEAN countries)

Regulatory Information management – Tracking

    • Migration to deliver regulatory submissions reliably and on time.
    • Regulatory tracking: management of the regulatory activities during the complete life cycle of the medicinal product

Regulatory consultancy

    • Validation OQ, PQ of eCTD tools and Regulatory tracking systems
    • CTD templates
    • Consultancy in the implementation of EDMS
    • RegInfo can also help you choose the right eCTD tool for your company.

Consulting for Life Sciences - Regulatory Affairs

    • Consultancy in dossier compilation for:
      • EU
      • USA
      • Emerging markets
      • Rest of the world
    • Product lifecycle:
      • New submissions
      • Renewals
      • Variation procedures
    • Worldwide labelling update
    • Scientific translation
      • Hungarian
      • English