Experience in R&D, Quality Control, Production and Over all operation, within the In-Vitro Diagnostics industry, I specialize in driving product quality and innovation for leading diagnostic brands in India. My expertise with a proven track record in developing and optimizing diagnostic assays. Key areas of expertise include: Rapid assay development (ELISA, Lateral Flow, Flow-through, etc..) Antibody purification (monoclonal and polyclonal) and antigen purification Regulatory compliance (ISO 13485, MDR 2017, WHO PQDX, CE Certification)