BioTeknica Engineering & Regulatory Services

Walking the regulatory compliance tightrope is not easy, but with BioTeknicas 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. Theyre 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 todays evolving regulatory environment. Our team of skilled scientists, regulatory professionals...

Quality and regulatory compliance,quality engineering,validation & commissioning,fda inspection readiness,lean quality solutions,483/warning letter/consent decree resolution,technical development services,is/it information systems management,iso 9001 certified,capa,risk management,iso 13485,21 cfr 820,data integrity,cybersecurity,and production & proces controls

Bioteknica engineering & regulatory services operates in the Medical equipment manufacturing industry.

Bioteknica engineering & regulatory services's revenue is 11m - 100m

Bioteknica engineering & regulatory services has 11 - 50 employees.