GMP APIs and IMPs
GMP active pharmaceutical ingredients (APIs)
Quotient Bioresearch offers radiosynthesis to GMP (third successful biennial inspection by MHRA in September 2008) for customers wishing to support clinical absorption, metabolism and excretion (AME) studies as well as microdose studies. We are able to advise on the design of GMP radiosynthesis and provide information for incorporation into the IMPD section of the CTA – including stability on storage information. GMP radiosynthesis is monitored by Quotient Bioresearch quality assurance who, in addition, release the radiolabelled APIs on completion of final analysis.
GMP investigational medicinal products (IMPs)
Quotient Bioresearch holds a GMP Manufacturing Authorisation for radiolabelled Investigational Medicinal Products (third successful biennial inspection by MHRA in September 2008). This authorisation covers solutions, liquid dose forms and solid dose forms (capsules and solids for reconstitution) for oral administration. GMP IMP manufacturing is monitored by Quotient Bioreasearch quality assurance and release for clinical use is carried out by a Qualified Person (QP).
Contact us for more information or to discuss your specific needs.