Mr. Krishna Chaitanya

Mr. Krishna Chaitanya is a Consultant at ToxMinds BV with more than 12 years of experience in Toxicology and Risk assessment of cosmetics, Over the Counter (OTC) drugs and medical devices. Prior to joining ToxMinds, Krishna in his previous organization Kenvue (previously Johnson & Johnson) performed the hazard and risk assessment of ingredients used in consumer products, actives and excipients in OTC pharma products and was instrumental in regulatory submission of non-clinical (2.4 & 2.6) sections in Common Technical Dossier (e-CTD) for > 20 products. Krishna worked on impurity qualification of the APIs under various need states, toxicological risk assessment of extractables & leachable in pharmaceuticals and medical devices as well as authoring of Biological Evaluation Plan/ Report (BEP/BER) for class I & II medical devices. Additionally, Krishna is entrusted with Human Hazard Evaluation, drafting responses to the health agency queries, deficiency reports and Product Due Diligence from safety perspective.

Krishna also has preclinical expertise in designing, conducting, and reporting preclinical toxicology (repeat dose, biocompatibility, and pharmacokinetics) and in vitro (hERG assay) studies as a study director for NCEs and ANDA, including audit experience with GLP and USFDA authorities for the submitted preclinical studies.

Krishna is a Diplomate in American Board of Toxicology (DABT) and holds a Master of Pharmacology degree from the JKK Nattraja College of Pharmacy, Dr M.G.R Medical University, Chennai, India.

Languages: EN, HI, KN, TE, TA

CONTACT

Mr. Krishna Chaitanya
Consultant

Phone: +91 80468 72426
Email: contact me

SPECIALITIES

Pharma, Cosmetics, Medical device (Class I & II), e-CTD (2.4 & 2.6), Regulatory toxicology, Non-clinical studies