Quality Assurance and Regulatory Affairs
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Preparation and filing of submissions for prescription and non-prescription drugs, biologics, veterinary products & devices
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INDs, NDAs, ANDAs
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DMFs and PMFs in compliance with current standards;
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Establishment License Applications.
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Good Laboratory Practice and QA Set-up and management of research laboratories in compliance with industry and government guidelines.
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Will Assume complete quality control function for companies without QC/QA :
-.Release products on time for market.
-·Comprehensive accurate reporting.
-Problem solving/recommendations.
-Complete product traceability.
-Complete SOPs /SOP manual
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GMP audits, As per FDA and HPFB, EMA and WHO requirements vendor/supplier audits, policy procedure review, and development
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GMP HPFB, EMA, FDA and WHO, MOP audits
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GMP Gap analysis, As per FDA and HPFB, EMA, and WHO requirements