Myself Quality practitioner with 24 + years experience in the field of Quality Assurance, Quality Control, Bioequivalence and Pharmaceutical Regulations and Regulatory Audit compliance. My quality management experience covers the implementation of Quality tools in bulk drugs, formulation companies and CRO. Mr areas of expertise covers Total Quality Systems as per cGMP, GLP, GCP and as per EMEA ,USFDA, MHRA and MCC,TGA,ANVISA, Japan guidelines. I am having competent QA/QC knowledge in API and formulation field of USFDA; cGMP, ICH Q8,Q9,Q10, Q7, EMEA cGMP, MHRA Orange Guide and OECD GLP guidelines. Having a strong background on regulatory guidelines for DMF, CTD Documents (ICH M 4 Q), ANDA...
