At Theraproval we are committed to offering regulatory support – whether your requirements are for high-level strategic advice or more hands aspects of regulatory affairs; including:

  • Regulatory project management
  • Lifecycle maintenance
    • Variations, renewals, PSURS
    • SmPC/Labelling development
  • Clinical studies regulatory support
    • New CTAs & CTA maintenance; EU CTR, FDA, global
    • DSURS
  • Scientific advice support
  • Change of ownership/license transfer
  • Grant applications
  • Innovative regulatory strategy development for:
    • Small & large molecule drug products
    • Medical devices
    • Combination products
    • Sterile products
  • Development of regulatory strategy documents
  • Act as regulatory Liaison (GRL or EU RL)
  • Independent & confidential due diligence (Investment, Acquisition or competitive)

 Our services can be provided on ad hoc, temporary, long term or discrete project basis.