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...