Cambridge Major Laboratories Europe (CMLE), a supplier of chemistry services supporting drug substance development, has successfully completed its first regulatory pre-approval inspection (PAI) for a commercial API. The audit of its Weert facilities was conducted over a two-day period from on Aug. 31 and Sept. 1. At the same time, the site's general certificate to manufacture drug substance intended for clinical trial application was renewed for another three years.
“This is a major step forward for CML Europe” commented general director Peter van Tilburg. “We have consistently invested in staff, procedures and facilities over the last 10 years, and this approval demonstrates our commitment to the highest quality standards. It is a result of all the hard work undertaken by every single team member, and our common vision for the future of CML.”
“We are already recognized as a development powerhouse,” added Roger McDonald, European business development director for CMLE. “This approval demonstrates our ability to provide top-quality services to clients at all development phases, from candidate nomination right through to commercial launch. Considering the recent announcement of successful FDA inspection at our new Grant Drive facility in the U.S., we feel this is a great testament to the quality CML Corporate is committed to meet. We want to be the long-term partner of choice for clients.”