BioTeknica Engineering & Regulatory Services

About BioTeknica Engineering & Regulatory Services

Walking the regulatory compliance tightrope is not easy, but with BioTeknica’s real-world quality expertise, life science manufacturing clients gain a competitive edge.

Medical device, diagnostics and pharmaceutical manufacturers are having to do more with less. They’re responsible for staying on top of an ever-evolving set of domestic and international regulations while bearing responsibility for every step in the global supply chain, increasing productivity and profitability and understanding how regulations apply to each specific product. BioTeknica provides engineering, quality and regulatory solutions that are S3 – Simple, Systematic and Sustainable for today’s evolving regulatory environment. Our team of skilled scientists, regulatory professionals and engineers have worked with hundreds of companies and has a solid track record of solving regulatory and compliance challenges for corporations, from Fortune 500 companies to start-ups.

Contact us. Balancing compliance and your bottom line is our top priority.

BioTeknica is an ISO 9001:2015 Certified Company.

Website	http://www.bioteknica.com
Employees	11-50 employees View all BioTeknica Engineering & Regulatory Services employees
Industry	Medical Devices
Location	2100 Ponce de Leon Blvd, Suite 1070, Coral Gables, FL 33134, US
Founded	1996
Keywords	Risk Management, Cybersecurity, Data Integrity, Iso 13485, Quality Engineering, Capa, Validation & Commissioning, 21 Cfr 820, Iso 9001 Certified, 483/Warning Letter/Consent Decree Resolution, Fda Inspection Readiness, Is/It Information Systems Management, Lean Quality Solutions, Quality And Regulatory Compliance, Technical Development Services, Production & Proces Controls