Gopal Krishna, Phd Email & Phone Number

Over 25 years of formulation development and commercial manufacturing experience of solid, liquid and parenteral dosage form of small molecules, large molecules, and biologics. Effective leadership, strong planning and organizational skills, strategic planning, good communication skills. Handled multiple projects with attention to detail. Management of contractual manufacture and supply chain of API and drug product. Provide technical expertise and CMC input during evaluation of new business opportunities, and co-development of late stage compounds. Thorough understanding of cGMP and GLP and CMC-related regulations and guidance documents for IND/NDA global submissionsWell rounded development experience taking drug from pre-clinical to IND/NDA stage. Proven success in developing formulations and manufacturing processes, transferring technology, creating procedures and documentation, and establishing regulatory compliance. Extensive experience in freeze drying technology, formulation development of parenteral dosage forms including parenteral emulsions, oral solid and liquid formulations, and analytical techniques.

Listed skills include Gmp, Pharmaceutical Industry, Technology Transfer, Biotechnology, and 20 others.