We offer trainings and consulting in the following areas:

Regulatory affairs

  • Regulatory strategy
  • Drug development
  • Agency interactions
  • Regulatory procedures
  • Submissions
  • CTD / eCTD
  • Artwork & labelling
  • Pharmacovigilance
  • Standard Operating Procedures (SOP)
  • Technical writing
  • Regulatory intelligence
  • Post-approval & life cycle management
  • Due diligence
  • Software selection & validation
  • European authorised representative
  • CE marking
  • Authorities & notified bodies
  • Product development
  • Technical file constructions & review
  • Essential requirements
  • Product classification
  • Artwork & labelling
  • Regulatory intelligence / survey
  • Vigilance
  • SOPs
  • Due diligence

Business Organisation

  • Interim management
  • Change management
  • Turn around management
  • Mergers & acquisitors
  • Due diligence
  • Regulatory compliance
  • Project management

Quality Assurance

  • Contact with notified bodies
  • Standard Operating Procedures (SOP)
  • Quality management
  • Risk management
  • Biocompatibility
  • Gap analysis

Our clients and partners

Find out more and contact us