At Theraproval we are committed to providing effective regulatory and product development consultancy.

Theraproval are delighted to offer you regulatory consultancy services whether your requirements are for high-level strategic advice or hands on regulatory document preparation & submission:

  • Marketing authorisation applications
  • Lifecycle maintenance
    • Variations, renewals, PSURS
    • SmPC/Labelling development
  • Clinical trial design & Clinical trial regulatory support
    • New CTAs & CTA maintenance
    • DSURS
  • Scientific advice
  • Change of ownership/license transfer
  • Quality assurance
  • Grant applications
  • Innovative regulatory strategy development for:
    • Small & large molecule drug products
    • Medical devices
    • Combination products
    • Software as a medical device
    • 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.

LinkedIn