Ministry of Health : Malaysia
We are excited to share with you that our Bioequivalence (BE) center has been approved by NPCB (National Pharmaceutical Control Bureau), Ministry of Health Malaysia.
We are one of only five BE centers in India having approval from NPCB, Malaysia. Here is the link of their website with details of approval.
http://portal.bpfk.gov.my/index.cfm?&menuid=31&parentid=82&highlightid=78
As Malaysia is part of PIC/S group of countries so a BE study conducted by us can now be submitted in PIC/S countries. Here is link for countries part of PIC/S (Pharmaceutical Inspection Co-operation Scheme).
http://www.picscheme.org/members.php
Our BE center is approved by CDSCO, India since 2007 and we have completed more than 80 BE studies for submission to ROW and CIS countries. Our CPP unit has a 30 bedded facility, which is designed to provide subjects the utmost safety, hygiene and comfort while offering a systematic flow for conduct of BA and BE studies.
We have a fully equipped ICU for handling potential emergencies, access controlled archive area for archival of documentation, biometric for volunteers participation and pharmacy area for investigational product and we present study protocols to a Sch Y and ICH GCP compliant Ethics Committee.
Our team has experience of conducting studies for various routes of delivery and formulations like Tablets, Capsules, Solutions, Suspensions, Syrups, Sprays, and Suppositories etc.
Our Bioanalytical facility is also accredited from NABL with globally accepted system and SOPs. Bioanalytical department is equipped with wide variety of analytical platform like LC/MS/MS, GC-MS-MS, ICP-MS, HPLCs, ELISA etc and having more than 60 validated methods as per US-FDA guideline.
With our regulatory support services which include new drug application, NOC from DCGI, Import License, and Sourcing of Innovator we are a full service CRO for bioavailability and bioequivalence studies.
We are grateful to you for your support and look forward to working with you soon!
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