Plant Audits and Regulatory
We audit the facilities and plants to ensure that
they comply with the FDA CGMP requirements as
specified by the norms of international regulatory
agencies such as the FDA (USA), Health Canada, the MCA
(UK), EDQM and EMEA (EU), the TGA (Australia), the MCC
(South Africa) and the WHO.
We prepare the suppliers/contract manufacturing
facilities to face pre-approval inspections. We assist
with inputs in responding to deficiency letters, if
any, until approval is achieved. We also oversee
post-approval manufacturing activities to ensure
regulatory compliance and product quality.