Dr. Shivadasan ANOOP
COO - TFM
Over 16 years of experience
My expertise spans various scientific disciplines, including teaching, surgery, toxicology, breeding, immunology, regenerative medicine, pathology, and physiology. Throughout my veterinary internship and professional career, I have held positions such as attending veterinarian, study director, manager, scientific assistant, and department head, contributing to specialized areas such as surgical procedures, sample collection, substance administration, breeding, treatment, behavioral assessment, safety pharmacology (telemetry), euthanasia, necropsy, and animal welfare. My experience encompasses a wide range of animal species, including dogs, rabbits, guinea pigs, cats, rats, mice, ferrets, Japanese quails, pigeons, zebrafish, goats, sheep, pigs, minipigs, cattle, and non-human primates.
Professional Profile
Laboratory Animal Science Expert, Attending Veterinarian, Toxicologist, and Experienced Surgeon
Establishment of the first commercial, CCSEA-approved Beagle breeding facility in India (Isoquimen India / Palamur Biosciences Pvt. Ltd.)
Initiation and establishment of the preclinical and non-clinical platform for the non-rodent division of pharmacokinetic and toxicokinetic studies at Palamur Biosciences Pvt. Ltd., encompassing various species such as dogs, minipigs, pigs, non-human primates, and cattle.
Establishment of the Safety Pharmacology – Telemetry Department at Palamur Biosciences Pvt. Ltd.
A key contributor to the establishment of the Medical Device Testing and Training Division at Palamur Biosciences, founded under the auspices of the National Biopharma Mission (NBM) and BIRAC.
Preclinical and Regulatory Toxicology Expertise across Multiple Sectors (Pharmaceuticals, Chemicals, Medical Devices, Food Safety, Environmental Toxicology)
Experience in Non-Clinical Study Design and Management, including In Vivo and In Vitro Studies
Toxicological Risk Assessments (e.g., PDE-OEL, Leachables/Extractables, Genotoxicity, Impurities, Ecotoxicology)
Expertise in Drug Development (IND, NDA, ANDA – 505(j), 505(b)2 Submissions)
Regulatory Experience with Global Authorities (USFDA, EMA, CDSCO, ANVISA, CFDA, TGA, MFDS, etc.)
Leadership Competencies (Management of CRO Collaborations, Regulatory Responses, Oversight of Preclinical Studies)

