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...
We鈥檝e updated our privacy policy so that we are compliant with changing global privacy regulations and to provide you with insight into the limited ways in which we use your data.
You can read the details below. By accepting, you agree to the updated privacy policy.
