Onyx Scientific excel in streamlining GMP-approved processes and difficult-to-synthesise APIs. Their compliance standards minimise impurities, reduce costs and significantly improve timelines for phase I and II clinical studies.
(1888PressRelease) March 09, 2011 - Leading chemistry services organisation, Onyx Scientific Ltd, is pleased to announce an increased demand for its early-phase, GMP synthesis, Investigational New Drug (IND) services for the development of Active Pharmaceutical Ingredients (APIs).
"At Onyx we plan for success by focussing on detail" explains CEO Tony Flinn. "Our service driven systems deliver comprehensive chemical route development, efficient raw materials sourcing, thorough analysis and world-class solid-state characterization. We are recognised as the leading GMP synthesis provider and are increasingly viewed as THE company to support the development of value for money INDs".
Dr Daryl Rees, Chief Executive, Salupont Consulting comments, "Having worked with Onyx Scientific for many years, I can say they are one of the finest suppliers in the marketplace. They have delivered a range of different services both on time and on budget, without hidden costs. Their GMP offering has been of particular use to us and we continually find that Onyx delivers excellent value for money".
An equally valued client adds, "I don't think there's another team I've worked with who respond so quickly and flexibly to the regulators, and to my many questions. All data generated is of the highest quality. My many calls are met with good humour, practicality, pragmatism and a lot of patience. It's genuinely rare to work with a partner who demonstrates such a high degree of commitment. Reagents were ordered ahead of me asking, Onyx worked late, missed holiday leave and ran experiments over the weekend. The service they provide is above and beyond anything I'd have expected and it has made my job here so much easier".
Good manufacturing practice (GMP) compliance is an international requirement for the manufacture of medicinal products for human and veterinary use. Compliance ensures medicinal products are produced safely and correctly. GMP Synthesis is the term commonly associated with manufacturing for Clinical Phases 1 to 3.
In addition to GMP synthesis and scale up, Onyx Scientific's breath of services include solid-form polymorph screening, salt selection, custom synthesis, process development and lead optimization.