Quality and Compliance Standards

Laboratory technician at terminal, smiling at camera

Since 1999, Therapak has been earning the respect and trust of its customers with a harmonized Global Quality Management System (QMS) which is reviewed during internal audits and customer audits. Therapak has four strategically positioned facilities in Los Angeles, Atlanta, London and Prague to offer our customers a reliable and compliant environment for Kit Production & Distribution solutions with a built-in Business Continuity Plan. Therapak’s regulatory certifications are identified below:

Location Certification Reference No.
Claremont, CA State of California Department of Health Services, Food and Drug Branch, Device Manufacturer License 74204
Claremont, CA California State Board of Pharmacy Wholesaler license WLS 6993
Claremont, CA Food and Drug Administration Department of Health and Human Services Owner/Operator 9002081
Claremont, CA Food and Drug Administration Department of Health and Human Services Registered Establishment 3010882984
Buford, GA Food and Drug Administration Department of Health and Human Services Owner/Operator 9002081
Buford, GA Food and Drug Administration Department of Health and Human Services Registered Establishment 3006450277
London, UK Department of Health, Medicines and Healthcare products Regulatory Agency ref CA 009316
Prague, CZ State Institute for Drug Control (SÚKL) Importer of diagnostic medical devices in vitro, Distributor of diagnostic medical devices in vitro, registration 006322
Claremont, CA State of California Department of Health Services, Food and Drug Branch, Device Manufacturer License 74204
Claremont, CA California State Board of Pharmacy Wholesaler license WLS 6993
Buford, GA Food and Drug Administration Department of Health and Human Services Owner/Operator 9002081
Buford, GA Food and Drug Administration Department of Health and Human Services Registered Establishment 3006450277
London, UK Department of Health, Medicines and Healthcare products Regulatory Agency ref CA 009316
Prague, CZ State Institute for Drug Control (SÚKL) Importer of diagnostic medical devices in vitro, Distributor of diagnostic medical devices in vitro, registration 006322


It is our policy to consistently deliver products and services that fully meet Customer specifications, company policies and procedures and regulatory requirements for the assembly and distribution of medical devices, convenience kits and procedure packs. Therapak will ensure our Client’s confidence by remaining current with supply chain developments, optimizing training methods, monitoring key quality performance metrics and continually improving our processes and services as part of an effective Quality Management System.

Therapak’s Quality Management System has been developed in compliance with regulatory standards to meet the needs of our global customer base and to improve the management practices of our company. The quality system operates in accordance to the United States Food and Drug Administration’s current Good Manufacturing Practices for medical devices – 21 CFR § 820, and Article 12 of Council Directive 93/42/EEC concerning medical devices, commonly referred to as the Medical Device Directive (MDD).