Bilcare Global Clinical Supplies, a leading global provider of Clinical Trial Materials (CTM) services to the pharmaceutical and biotechnology industries, has received Certificate of GMP Compliance of Manufacturer from National Pharmaceutical Control Bureau, Ministry of Health, Malaysia.
This certificate comes after going through strict inspection conducted in accordance to the stringent guidelines of Malaysian Control of Drugs and Cosmetic Regulation and Malaysian Drug Registration Guidance Document (DRGD) and complies with principle and guidance of the current Pharmaceuticals Inspection Co-Operation Scheme (PIC/S)) GMP guidelines and its scope covers a wide range of services offered in the CTMS field like-Primary & Secondary Packaging, Labelling, Storage & Distribution of various formulations and drugs both critical and generic in nature.
According to Ajit Dubhashi, chief executive officer, Bilcare GCS, ICS certification from Malaysia confirms our quality commitment and proven track record of successfully conducting various global trials conforming to USFDA/MHRA guidelines. The new PIC/S certification will now enable Bilcare GCS to support trials commencing in 44 participating countries, falling under the PIC/S scheme.
PICS certification is valid in 44 listed countries, including Australia & few CIS countries. Japan and Korea are being added from July 2014 and thus opening new business opportunity doors for Bilcare GCS in these countries. Further, it will facilitate Pharmacos, Clinical Research Organizations (CROs), Government Bodies, Institutions and Labs conducting various Clinical Trials to avail unmatched quality services coupled with speed to market and offer value for investments.
Bilcare GCS is also accredited with ISO 9001:2008 by TUV SUD, management service, GmbH for its ability to demonstrate quality, compliance/regulatory requirements and consistently provide product and services that exceeds customer expectations.