Alok Kumar Chaudhary

- Support feasibility, development, ICH and regulatory stages of product life cycle. - Intensive engagement in quality system implementation, new lab infrastructure development.

- Led competent team of 18 scientists to support product development related activities. - Primarily involved in solid oral dosage forms, high gravity solid state characterization and dissolution development studies. - Crystalline form studies, EI, GTI and Nitrosamine assessments, development to production bridge-in studies. - Met deliverables in a highly dynamic environment.

- Led a competent team of 6 scientists to support feasibility, development, ICH and regulatory stages of product development of oral solids and small volume injectables. - Intensive engagement in CSV, custom fields calculations, quality system implementation, complex projects, combination products, troubleshooting, NDPS handling, training and development. - Preparative isolation, small molecule characterization, standard qualification etc.

- Led a competent team of 4 scientists to support product development of oral solid, transdermal and small volume injectables. - Statistical simulations, characterization studies, stability support.

- Small molecule characterization, statistical simulations, solid state research and characterization, DoE based chromatographic developments, peptide and protein analysis, early phase lead research, advance sophisticated instrument operations.

Led a competent team of 4 scientists to support product development of oral solid, transdermal and small volume injectables.

Quality Assurance

Pharmaceutical Sciences