CL Tech Inc.
Irvine, United States (US) · Health and Medical
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#validations
#quality engineering
#compliance
#quality assurance
#sdlc
#gamp5
#medical devices
#biotech
#pharmaceuticals
#api
CL Tech Inc is a California-based Quality Engineering and Validation Services provider specializing in regulatory compliance and quality assurance for the Biotech, Pharmaceutical, and Medical Device industries.We support companies navigating complex FDA and EMEA regulations, including 21 CFR Part 820, ISO 13485, and GAMP5.
Overview
We support companies navigating complex FDA and EMEA regulations, including 21 CFR Part 820, ISO 13485, and GAMP5. Our team of experienced professionals offers a comprehensive suite of services, from Design Validation and Equipment Qualification to Process Validation and Computerized System Validations.
CL Tech Inc. distinguishes itself through a commitment to meticulous detail, a deep understanding of risk management principles, and a proven track record of successfully resolving regulatory challenges and achieving zero audit findings. We provide both on-site and remote support, leveraging technology and expertise to ensure our clients meet the highest standards of quality and compliance.
Contact Details
Irvine, United States (US), 13 Lassen
+4
Founded
2003
Company Type
Sole Proprietorship
Employees
2-10
Categories
Keywords
#validations
#quality engineering
#compliance
#quality assurance
#sdlc
#gamp5
#medical devices
#biotech
#pharmaceuticals
#api
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