PROFESSIONAL EXPERIENCE
Regulatory Experience:
Prasanna
Krishna V
Biocompatibility
Specialist/Toxicologist
Toxicologist with over 7.5 years’
experience in the field of biological
safety evaluation of medical
devices, pharmaceuticals, and risk
assessment of cosmetics. Extensive
knowledge in global regulatory
standards such as ISO, EU MDR,
OECD, ICH etc. and
chemical/material risk management
with a proven track record of
achieving results.
(+91) 9652248297
Chennai, 600100
Prasannakrish.vedag@hcl.com
Technical Lead Nov 2021 – Present
HCL Technologies Ltd, Chennai, India
• Biological Evaluation of Medical Devices as part of EU MDR 2017/745
remediation plan in compliance with ISO 10993 Standards
• Perform Gap analysis to EU MDR 2017/745 and ISO 10993 test
standards.
• Preparation of Biological evaluation plans (BEP) and Biological
Evaluation reports (BER) for medical devices
• Design, review, and monitoring of biocompatibility and chemical
characterization studies (E & L studies) including review of test plans
and reports.
• Perform Toxicology Risk Assessment (TRA) for both raw materials and
Extractables or Leachable including calculation of Margin of Safety
(MoS) in accordance with ISO standards.
• Conduct literature search in various public and commercial toxicological
databases to extract toxicological end points
• Train and Mentor Junior resources
Lead Associate, Consumer Health R&D
Toxicology May 2019 – Nov 2021
WNS Global services. Gurgaon, India
• Safety evaluation of cosmetic ingredients, flavours, botanical
ingredients, and pharmaceuticals in compliance with European and US
regulations
• Drafting regulatory safety reports viz., Periodic Benefit-Risk Evaluation
Report (PBRER), Development Safety Update Report (DSUR), Addendum
to Clinical Overview (ACO) and New Drug Application (NDA) for
marketed drugs
• Risk assessment of finished cosmetic products, food and dietary
supplements, and OTC drug products including Margin of
Safety/Exposure (MoS/MoE) calculations
• Risk assessment of impurities in drug and cosmetic products in
compliance with ICH Quality documents and weight of evidence
analysis using in silico toxicology tools
Executive-Toxicology
Jan 2018 – May 2019
iMED Global Solutions – Hyderabad, India
• Literature search of available toxicological data on cosmetic
ingredients, flavors, pharmaceuticals, pesticides and household
products, followed by data gap analysis
• Preparation and review of safety assessments of fragrance and flavor
ingredients.
• Impurity qualification in pharmaceuticals including derivation of
Permissible Daily Exposure (PDE) limits.
 Pre-Clinical Testing Experience:

Research Associate-Toxicology
Dec 2015 – Jan 2018
Laila nutraceuticals R&D centre– Vijayawada, India
• Conducted various acute toxicity studies such as Acute Oral Toxicity,
KEY SKILLS dermal toxicity, eye irritation, dermal irritation, and skin sensitization
studies in both rodents, such as mice, rat, guinea pigs and non-rodents
such as rabbit in compliance to OECD Test Guidelines and GLP.
• Pre-clinical Toxicology
• Conducted various repeated dose toxicity studies such as sub-acute,
• Biocompatibility sub-chronic toxicity studies in both mice and
• Toxicological Risk Assessment reproductive/developmental toxicity screening assays in rat according
to OECD test guidelines
• In silico Toxicity predictions
• Drafted various Study Plans and Study Reports in compliance with
• Benchmark Dose (BMD) Global Regulations.
Calculation
• Played a pivotal role in validating and achieving GLP certification for
• Read-across approach sub-chronic toxicity study, functional observation battery assays,
• Data mining Reproduction/Developmental toxicity screening assay and Skin
sensitization study
REGULATORY KNOWLEDGE

• ISO 10993 Standards EDUCATION

• ISO 14971, 13485 Master of Pharmacy (Pharmacology), 8.2 CGPA

• MDR 2017/745 Andhra University, Visakhapatnam Dec 2015

• OECD, ICH, EMA Test Bachler’s of Pharmacy, 71.14%

Guidelines
Saastra College of Pharmacy, Nellore April 2012
• GLP and GDP
Intermediate, 92.2%
ADDITIONAL SKILLS
Sree Sai Junior College, Nellore April 2008

• Problem solving abilities Secondary School Education, 82.2%

• Adaptability Sarada English Medium High School, Nellore April 2006

• Teamwork
PUBLICATIONS
Sri Rekha V, Prasanna Krishna V. Pharmacological Study of the Methanolic
Whole Plant Extract of Eclipta alba Against Ischemic Reperfusion Injury on
Kidney of Sprague Dawley Rats. International Journal of Pharmacognosy and
Phytochemical Research 2019; 11(3);105-115. doi: 10.25258/phyto.11.3.3

CONFERENCES AND WORKSHOPS ATTENDED

• Completed “Dose-response assessment Boot-Camp” by TERA, Unites

States of America, Conducted at Thrissur Kerala in Oct 2022
• Presented a poster titled “in silico toxicity prediction of therapeutic natural
products” at 10th annual meeting of American Society for Cellular and
Computational Toxicology (ASCCT). 2021
• Participated in workshop “Sensitization workshop on GLP” conducted by
NGCMA at New Delhi-2017.
• Presented Poster titled “Hepatoprotective activity of Phyllanthus amaras”
at 2nd International conference of society of pharmacognosy-2015.