Through our significant experience in the pharmaceutical sector, including our R&D team, our quality and regulatory experts, and our industrial partners, we develop and market high value-added products for both humans and the veterinary field.
R&D
Our fundamental research is the result of strong collaborations between our product development team, the Gly-CRRET laboratory (“Glycosaminoglycans sulfates and homeostasis”; “Cell growth, repair, and tissue regeneration”) at the University of Paris Est Créteil Val-de-Marne as well as with various academic partners worldwide.
Subcontracting
Our subcontractors (raw materials, manufacturing) are regularly audited under the supervision of our Regulatory Quality teams in order to guarantee an effective Quality Management System (QMS) corresponding to industry standards (ISO 13485:2016, GMP).
Batch release is performed by OTR3 according to the QMS approved by our regulatory agencies.
Quality Management System
ISO 13485:2016 provides the guidelines for an organization to establish a quality management system which demonstrates the ability to consistently provide medical devices and related services that meet the requirements of both the customer and the applicable regulatory authorities.
OTR3 products for human medicine are certified by NSAI (National Standards Authority of Ireland) to ISO 1345:2016, MDD (Medical Device Directive).
Vigilance
Material vigilance, also known as post-market surveillance or material adverse event reporting, is a crucial aspect of ensuring the safety and effectiveness of medical devices. It involves monitoring the performance and safety of medical devices that have been placed on the market to identify and assess any adverse events, malfunctions, or issues related to their use.
Should you encounter any adverse effects while using any of our products, please contact us promptly via phone at +33 (0)1 83 64 23 00 or email at qual@otr3.com.
Your safety is our utmost priority. We will conduct a rigorous medical assessment, and if deemed necessary, we will promptly report the adverse event to the appropriate regulatory authority.
