AASTRID INTERNATIONAL (PVT) LTD.

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Services - Plant Audits


   Plant Audits and Regulatory Compliance
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.

 

 

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