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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

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

Date founded

1996

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