Regulatory Services

Regulatory Services for Medical Device & Pharmaceutical

Regulatory Services for Medical Device & Pharmaceutical

BioTeknica provides expert clinical and regulatory support for all phases of global medical device and drug development. We support clinical and regulatory activities in the USA, European Union, as well as the emerging Asia Pacific, Latin American, Central and Eastern European markets.  Regulatory Services include support of: new chemical entity development, clinical trials, marketed products, generics, OTC products, medical devices, as well as regulatory activities related to mergers and acquisitions.

Not sure of your strategy?  Our experts provide second opinions for your regulatory questions, and we assist sponsors in negotiations with select regulatory agencies.

Regulatory Services:

  • EU Submissions & Registrations
  • 510 (k), PMA and BLA Submissions
  • Bio-Statistics
  • cGMP Risk Analysis
  • Recalls, Field Corrections & Safety Alerts
  • Clinical Trials
  • Post Market Surveillance and Reporting
  • Import Alert & Detention Removal Programs
  • Major Product’s Liability Litigation
  • Import Alerts/Bans
  • Monitoring of North American & European Union Regulatory Activities
  • Regulatory, Quality & Clinical Trial Planning
  • New Product Determinations – Device, Drug, Biologic & Combinations
  • Training & Education
  • Risk Analysis