Do you need top level regulatory help? Are you concerned about future regulatory requirements? Do you want to reduce regulatory risk? Do you have a compliance problem? Do you need a due diligence audit?

Regulatory consulting services.

  • Interpretation of regulatory requirements (advice and expert opinion)
  • Resolving risk classification and borderline problems
  • Conflict resolution with Notified Bodies, UK Approved Bodies and National Competent Authorities
  • Technical expertise in court cases
  • Setting up authorised representative services in the European Union

One stop shop service.

  • Comprehensive assistance from initial product concept to market using our customised virtual teams

Workshop and training service (in house, off site and virtual).

  • Any aspect of compliance life cycle covered
  • Highly focused workshops on:
    • Post-market surveillance including vigilance
    • Risk classification and borderline determination

Dealing with Brexit

  • Advice on the new evolving British regulatory requirements
  • Acting as your UK Responsible Person
  • Acting as a legal representative for clinical trials carried out in the UK