Leveraging our extensive experience in the pharmaceutical sector—including our R&D teams, quality and regulatory experts, and industrial partners—we develop and market high value-added products for both human and veterinary applications.
R&D
Our fundamental research is driven by strong collaborations between our product development team and 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 multiple academic partners worldwide.
Subcontracting
Our subcontractors (raw material suppliers and manufacturing partners) are regularly audited under the supervision of our Quality and Regulatory teams to ensure an effective Quality Management System (QMS) in compliance with industry standards, including ISO 13485:2016; GMP.
Batch release is performed by OTR3 in accordance with the QMS approved by the relevant regulatory authorities.
Quality Management System
ISO 13485:2016 provides the framework for organizations to establish a quality management system that demonstrates the ability to consistently deliver medical devices and related services in compliance with customer requirements and 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 referred to as post-market surveillance or medical device adverse event reporting—is a critical component in ensuring the safety and performance of medical devices. It involves the ongoing monitoring of medical devices placed on the market to identify, evaluate, and address adverse events, malfunctions, or other 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 highest priority. We will conduct a thorough medical assessment and, if necessary, promptly report the adverse event to the appropriate regulatory authority.
