Therapak is a cGMP compliant company, registered with the FDA as a Re-packager and Re-labeler of medical products. As a manufacturer of Convenience Kits, Therapak has been audited over the years by major Pharmaceutical, Biotech and Laboratories and continues to demonstrate its compliant focus on quality through Continuous Improvement programs.
In Europe, the term Procedure Packs is used to describe these kits which fall under Article 12 of the Medical Devices Directive. As the Competent Authority in the United Kingdom, Therapak is registered with the Medicines and Healthcare products Regulatory Agency (MHRA) and subject to the same quality standards as in the US.
Therapak’s quality process is governed by a Quality Manual with oversight by Regulatory Affairs and Quality Assurance. Each Therapak facility has dedicated Quality Control experts who administer to the quality requirements in order to provide consistent product quality regardless of what facility is servicing your needs.