Hire Yaswanth Inabathina, a pharma consultant specializing in Analytical Testing, Medical Devices and Pharmaceutical Quality. See services offered, experience summary, and connect via apicule.
Based in: India
Willing to work in: Global
Consultant Type: Independent Consultant
Expertise summary: Yaswanth Inabathina is an analytical R&D and quality systems professional with a research background in cancer biology and molecular biotechnology. His expertise includes analytical development, method validation, stability studies, quality management systems, CAPA, and regulatory compliance support. His research interests and capabilities also span genome sequencing, CRISPR-Cas9 gene editing, and machine learning applications in biological research. At TCG GreenChem, he developed and validated analytical methods and conducted drug-substance stability and impurity-profiling studies within a GMP environment. His consulting experience includes audit documentation, non-conformity reporting, document control, and data integrity practices. His research background combines cell-based evaluation of oncology compounds at Tuskegee University with crop genome-editing work at ICRISAT. He helps pharmaceutical teams strengthen analytical documentation, characterize drug substances, and address quality-system gaps through documented corrective and preventive actions. - Show More
Yaswanth supports analytical development for drug substances through experience developing HPLC, LC-MS/MS, GC, and NMR methods. His work includes impurity profiling and analytical characterization for oncology and other pharmaceutical research programs. He helps development teams investigate analytical requirements, interpret findings, and prepare supporting records within GMP and data integrity practices.
Yaswanth supports CAPA activities arising from management-system audits and documented non-conformities. His consulting experience includes preparing audit reports and supporting corrective and preventive action documentation across pharmaceutical and other industries. He helps teams connect audit findings with supporting records and document actions addressing identified quality-system gaps.
Yaswanth supports analytical method validation through hands-on experience developing and validating methods for drug-substance R&D. His work at TCG GreenChem included analytical activities under ICH Q2(R1), using chromatographic and spectroscopic techniques. He helps laboratory teams execute validation studies and document results supporting the intended use of analytical methods.
Yaswanth supports quality management systems through experience preparing audit documentation and reports against ISO 9001 and other management-system requirements. His consulting work includes documenting conformities and non-conformities, supporting document control, and applying ALCOA+ data integrity practices. He helps organizations organize quality records and document findings requiring follow-up.
Yaswanth supports pharmaceutical stability programs through experience conducting drug-substance stability and impurity-profiling studies. His background combines analytical method development with laboratory work in a GMP environment. He helps teams generate and interpret analytical information from stability studies and maintain supporting documentation for development programs.
