Laxmi Varshney

GLOBAL REGULATORY AFFAIRS &
PRODUCT REGISTRATION

Regulatory Affairs and Registration professional with 10 Years of
experience in Agrochemical industries. Product developing and
implementing regulatory strategies that achieve compliance with
government regulations. Well versed in managing cross-functional
teams, building relationships with key stakeholders and
communicating complex information in a clear and concise manner.

• Regulatory Toxicology
• Principle of Toxicology
• Methods of Toxicology
• Pesticides and Heavy Metals Toxicology
• Molecular Toxicology
• Sound knowledge of Registration Requirement of Agrochemicals, Biopesticides, Household pesticides and others

• Preparation of Documents and filling up Registration files and upload on the CIB website for Agrochemicals Registration U/s 9(3B), 9 (3), 9(4) category of CIB & RC India.
• Preparation of Endorsement files like bio efficacy claim, source addition, alternate packing etc .

• Dossier preparation for Agrochemicals/public health use products/vet Registration for Overseas Country.
• Toxicity Studies (Acute, Sub Acute, Genotoxicity, Ecotoxicity), Acute Oral Toxicity, Acute Dermal Toxicity, Acute Inhalation Toxicity, Primary Skin Irritation and genetic tests.
• OECD Guidelines for Toxicity studies and Regulation of chemical testing.
• Regulatory aspects (OECD, US EPA, EFSA, ECHA, FAO, WHO, GHS).
• Risk assessment and risk minimization strategies, Hazardous chemicals classification and labeling as per GHS.

• Expertise in animal handling (Wistar rats and Swiss albino mice) for study-treatment sacrifice & injections through various routes like oral (p.o), intra peritonial (i.p.), intra muscular (i.m.), sub cutaneous (s.c.).
• Working Knowledge of handling of instruments like, Centrifuges, Spectrophotometers, Autoclave, Gel DOC.
• Techniques like Agarose Gel Electrophoresis, PAGE, DNA isolation, chromatography, Thin layer chromatography (TLC), PCR, Blotting.
• Neurobehavioral experiments like Morris Water Maze (MWM), Rota Rod, Cooks pole.

• Protein estimates in BSA
• Sugar level in serum
• Cholesterol level in serum
• Uric acid level in rat serum
• Bilirubin levels in rat serum
• LDH level in blood serum.
• Blood urea nitrogen (BUN) level
• Creatinine levels in rat serum
• SGPT levels in rat serum
• SGOT levels in rat serum
• Various enzymatic and non-enzymatic toxicological parameters like Glutathione peroxidase (GPx), Catalase, Glutathione (GSH), Lipid peroxidation (LPO), Glutathione reductase (GR), Superoxide Dismutase (SOD), Nitric oxide (NO), Xanthine oxidase (XO), Glutathione S transferase (GST), Quinone reductase (QR), Protein Carbonyl (PC), etc

• Isolation of Brain by Decapitation, isolation of internal vital organs (liver, brain kidney, etc..) to check the overdose toxicity & for histopathology in Wistar rats & mice (SAM).
• Sacrifice of animals (wistar rat and mice) used in study by cervical dislocation and local anesthesia.
• Bleeding in rats & mice for hematology & biochemical evaluation.
• Perfusion of organs during sacrifice of animal.

• Determination of exposure toxicant through various routes of administration.
• Estimation of effect of Pesticides in Acetyl cholinesterase (AchE), Na+-K+ ATPase pump, Monoamine oxidase (MAO) in rat brain.

• DNA Isolation and purification.
• Polymerase chain reaction (PCR)
• Agarose gel electrophoresis, 2D Electrophoresis, SDS-PAGE, Western blotting.
• Chromatography (Paper, Thin layer, Gel permeation, HPLC)
• Cell culturing technique (Microbiology)

• Visit to Renowned Research Institutions like Central Drug Research Institute (CDRI), Indian Institute of Toxicological Research (IITR), Biotechnology Park, Center for Medicinal and Aromatic Plant (CMAP) at Lucknow during March'13.
• Visit to Asia's Biggest Animal House at IITR, Lucknow.

• Date of Birth: 03/01/89
• Gender: Female
• Marital Status: Married