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?
Bāgepalli 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
temperately 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