The inspection in January focused on our Bioanalytical Department, while the more recent inspection in May was directed at our Clinical Operations. Both inspections were triggered by clinical studies conducted at our site for sponsors preparing to enter the U.S. market.
We are proud to share that we passed both inspections.
This achievement also aligns with the recent NDA approval of Vyscoxa™ (celecoxib oral suspension).
Our US partner, Kiel Laboratories, developed and received FDA approval for the product, while Quinta-Analytica contributed with a bioequivalence study and selected CMC activities.
This collaboration underlines the importance of strong partnerships in ensuring successful product development and market access. Moreover, you will be able to meet representatives of Kiel Laboratories at this year’s CPHI, where we have once again invited them to join the Conscio Group booth as our strategic partners for the U.S. market.
In conclusion, these inspections represent not an exception, but part of a long-standing tradition of passed audits that Quinta-Analytica has successfully undergone over the years.
We remain fully GLP, GCP, GMP and FDA certified.
Conscio group is a scientific service provider committed to improving the safety and quality of pharmaceuticals, food and our environment. Beyond clinical and analytical expertise, the Group offers GMP manufacturing solutions for investigational medicinal products (IMPs), as well as formulation development and technology transfer across multiple dosage forms. Learn more at www.conscio.group
