Regulatory Affairs Services

  • Drug development phases (I-III):
    • Clinical Trial Authorisation (CTA) applications
    • Orphan designations
    • Pediatric Investigation Plan (PIP)
    • Scientific Advices
    • Regulatory strategies in drug development and marketing plans
    • Writing CMC documents
    • Preparing of high quality regulatory documents
    • Review of all scientific documents  (non-clinical, clinical)
    • Answering CTA deficiency letters
    • Creating of regulatory and scientific guidelines
    • Interpretation of legislations and guidelines
  • Marketing Authorisation Applications (MAA):
    • CP
    • MRP/DCP/national
    • Review and input to all labeling components
    • Scientific advices
    • Review of and input to all scientific documents and dossier components
    • Answering MAA deficiency letters
    • Supervision CTD/eCTD process
  • Maintenance and LCM:
    • Variations
    • Justification of change controls in the light of regulatory status in different regions (EU/US/CA/ITC)
    • Indication expansions
    • Line extensions
    • Renewals/PSURs
    • Creating/update labeling components acc. to QRD (e.g., after CP), CCDS
    • CMC compliance checks (GMP/site practices vs. regulatory documentation: EU, US, CA, ITC)
    • Writing CMC documents
    • Implementation of Risk Management Plan (RMP)
    • Creation and revision of educational material to HCPs and patients
    • Review of and input to all scientific documents

Further services:

  • Interim RA management on- and off-site
  • Building up RA divisions from scratch
  • Leading RA staff and project teams
  • Trainings to interdisciplinary teams
  • Translations