Singapore is a provisional signatory to the OCED Mutual Acceptance of Data (MAD) agreement and there are a large number of GXP operations there already including many major pharmaceutical firms’ manufacturing and clinical operations.
Leigh Berryman, Maccine’s CEO and a certified GLP professional, commented on the successful audit “Maccine has been GLP compliant for some time and although we have already submitted studies to the FDA and other authorities almost half our customers are from OECD countries where this GLP framework is typical. This will certainly give confidence to those who have not yet visited us and convenience to those who do not have audit teams.”
Studies conducted at Maccine under full Quality Assurance control are those that are likely to be submitted as part of Investigational New Drug (IND) or Clinical Trial Authorisation (CTA) applications such as repeat dose toxicology studies and cardiovascular safety pharmacology.
Other safety pharmacology studies such as abuse liability assessment, that have historically not required GLP compliance, can also be conducted under GLP in the neuroscience centre at Maccine’s Singapore research site.
About Maccine:
Maccine is a Singapore based preclinical contract research organisation providing innovative discovery support and quality safety assessment services to the global biotech and pharma industry.
