Regulatory Services for Medical Device & Pharmaceutical Industries
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.
EU Submissions & Registrations
510 (k), PMA and BLA Submissions
cGMP Risk Analysis
Recalls, Field Corrections & Safety Alerts
Post Market Surveillance and Reporting
Import Alert & Detention Removal Programs
Major Product’s Liability Litigation
Monitoring of North American & European Union Regulatory Activities
Regulatory, Quality & Clinical Trial Planning
New Product Determinations – Device, Drug, Biologic & Combinations