Each product is unique and the well planned regulatory strategies are important for their approvals. Educe provides expert clinical and regulatory support for all phases of global drug development.
      We support clinical and regulatory activities in the USA, European Union, as well as the emerging markets of Asia Pacific, Latin America, and Central and Eastern Europe. Educe works with the companies to provide a seamless progression for drug registration.

Our services include:

Strategic planning and Consulting

  • > Development and execution of regulatory strategies
  • > Lifecycle development planning
  • > Regulatory gap analysis & due diligence
  • > Protocol development and production
  • > Scientific advice, expert oversight and review of data
  • > Document authoring and review services
  • > Advice and strategy for European and FDA submission procedures
  • > Interpretation of guidelines and opinion on regulatory requirements
  • > Agency management & liaison
  • > Follow-up strategies and action

Regulatory Submissions and Support

  • > Applications for new drugs and line extensions (centralised, decentralized, mutual Recognition and national)
  • > CTD preparation of modules, overviews and summaries
  • > Licence renewals and Variations Type I and Type II
  • > Orphan drug applications
  • > Summary of Product Characteristics, Patient Information Leaflet and labeling
  • > Prescribing information preparation and review
  • > Clinical trial applications
  • > Paediatric Investigational Plans
  • > Promotional material review and approval

Post-approval & Maintenance

  • > Variations and supplements
  • > Maintenance and regulatory life cycle management
  • > Full Pharmacovigilance and drug safety services
  • > Submission Planning and Management (eCTD / NeeS / Paper)
  • > Resource Planning and Coordination
  • > Content Publishing and Tracking
  • > Submissions Assembly and Review
  • > Component Compliance Checking
  • > Submission Dispatch
  • > Copyright Clearance