Appalaraju Gorle

About Appalaraju Gorle

Board certified Toxicologist with 9+ years of experience in the design, execution, and monitoring of toxicology studies conducted in various laboratory animals (Rodents, Non-rodents, and Non-Human Primates.) for pharmaceuticals, biopharmaceuticals, and medical devices as per OECD, ICH, and ISO 10993 for successful submission. Toxicological evaluation and Safety assessment (Calculation of ADI, PDE, PEL, OEL and MACO etc,) of raw materials, intermediaries, and finished products for small molecule generics and excipients. Thorough use of In-Silico Toxicology prediction tools viz. DEREK-SARAH, OECD Toolbox, Toxtree for risk assessment of data deficient compounds. Preparing the Biological Evaluation Plans and Biological Evaluation Reports according to ISO 10993 and ISO 14971. Preparing the Toxicological Risk Assessments (TRA) for potential leachables from medical devices. Provided Gap-analysis for biocompatibility-related Standards and Guidelines (ISO 10993 series, OECD, ASTM, FDA). Provided on-site support to Medical Device manufacturers to remediate Quality Systems failures. Specialties: Toxicology, Risk Assessment, and Medical Devices.

Experience

1. Toxicologist

   Medtronic

   Dec 2021 — Present · IN

   Preparing preclinical study outline data by understanding the specific regulatory requirements and project constraints to ensure the successful conduct of studies, cost-effectively, and within timelines.\\\\nWorking with CROs and internal team to enable preparation, review, and finalization of the study protocol as per the defined strategy to ensure that protocol is approved by all relevant stakeholders and/or regulatory authorities within targeted timelines.\\\\nAuthor of Biological Safety Evaluations and Risk Assessments according to ISO 10993 and ISO 14971.\\\\nAuthor of Toxicological Assessments for potential leachables.\\\\nProvided Gap-analysis for biocompatibility related Standards and Guidelines (ISO 10993 series, OECD, ASTM, FDA)\\\\nProvided on-site support to Medical Device manufacturers to remediate Quality Systems failures.\\\\n \\\\n\\\\n \\\\n \\\\n\\\\n \\\\n

Education

• The Tamilnadu Dr.MGR Medical University

  Master of Pharmacy, Pharmacology and Toxicology, A

  2010 — 2012

• Andhra University

  Bachelor of Pharmacy (B.Pharm.), Undergraduate, A

  2006 — 2010