Niraj Patel Email & Phone Number

Ahmedabad, Gujarat, India

Ahmedabad, Gujarat, India

 Responsible for review and development of systems. Guiding for Method development and Method validation of Bio analytical methods in a perfectly maintained GLP environment by UPLC & LC/MS/MS. To respond the Deficiency letters of Regulatory Agency. To plan project activities for analytical operations.  To authorize the project in charge and the.

Ahmedabad Area, India

 Accomplished and cleared regulatory audits conducting EMEA, USFDA (twice), WHO, Thailand FDA, NPRA (Malaysia) and DCGI for clinical facility maintained within CRO-Cadila pharmaceuticals Ltd. Leading the clinical investigation and performing root cause analysis with respect to non- conformance observed during the clinical site inspection. Assists with.

Ahmedabad Area, India

 Primary responsibilities include leading the bioanalytical group of 3 scientists at Synchron in support of Method development, method validation and biostudies. Development and validation of new bioanalytical procedures for monitoring drugs and metabolites in the biological fluids using LC-MS/MS as per USFDA & BRAZILIAN guidelines. Responsible for.

M.Sc, Organic Chemistry

Bachelor Of Science (B.Sc.), Chemistry