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BioTeknica Engineering & Regulatory Services

50 employees

BioTeknica operates as an engineering and regulatory services consulting firm to manufacturers of medical devices and pharmaceuticals.

Basic info

Industry

medical equipment manufacturing

Sectors

Validation & Commissioning
Industrial Engineering
Biotechnology
Data Integrity
ISO 13485
FDA Inspection Readiness
Cybersecurity
Production & Proces Controls
483/Warning Letter/Consent Decree Resolution
Quality Engineering
Technical Development Services
Risk Management
Professional Services
CAPA
Quality and Regulatory Compliance
ISO 9001 Certified
Medical
21 CFR 820
IS/IT Information Systems Management
Lean Quality Solutions

Date founded

1996

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