Ditiksha Mandanka profile photo 1 on Tal

Ditiksha Mandanka

Scientific & Regulatory Writer | Toxicology Research | Medical Device Safety Evaluation | GLP Documentation | M.Sc. Microbiology

Bengaluru

2+ years of work experience

Accuprec Research Labs Pvt. Ltd.
Dec 20247 mosJun 2025

Led end-to-end documentation for GLP-compliant in vitro toxicology studies supporting medical device safety evaluations. Authored and finalized study protocols, technical reports, and final summaries aligned with regulatory expectations. Translated complex raw experimental data into structured scientific narratives, tables, and defensible conclusions for cytotoxicity, hemolysis, Ames, and genotoxicity studies. Served as Study Director, ensuring data integrity, documentation accuracy, traceability, and audit readiness across all study phases. Developed and maintained SOPs, internal documentation, and standardized report templates to strengthen compliance and consistency. Collaborated cross-functionally with scientific and quality teams to deliver precise, regulatory-facing documentation for sponsors, auditors, and reviewers.
Accuprec Research Labs Pvt. Ltd.
Dec 20222 yrs 1 moDec 2024

Supported the Study Director across all phases of GLP-compliant in vitro toxicology studies, from protocol development to final reporting. Managed phase-specific documentation, raw data records, deviations, and amendments in alignment with GLP requirements. Prepared audit and regulatory submission documents (OECD, ISO 10993), ensuring accuracy and traceability. Maintained laboratory compliance through documentation control, equipment records, and data integrity practices, ensuring continuous audit readiness.
NEUBERG SUPRATECH REFERENCE LABORATORIES
Oct 20223 mosDec 2022

Ahmedabad, Gujarat, India

done Internship at Neuberg Supratech reference laboratory - Genomic medicine sponsored by Gujarat biotechnology Research Centre - Industrial Biotechnology Training Program In this training program, I spent 1 week for each department to know the overview of techniques.

Education

Institute of Advanced Research, Gandhinagar

Master's degree, Microbiology, General

Institute of Advanced Research, Gandhinagar

20202 yrs2022

Bachelor of Science - BS, Microbiology, General

Lj institute of applied science

20173 yrs2020

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Ditiksha Mandanka on Tal

Headline

Scientific & Regulatory Writer | Toxicology Research | Medical Device Safety Evaluation | GLP Documentation | M.Sc. Microbiology

About

Scientific Writing and Regulatory Documentation professional with 2.5+ years of experience supporting medical device safety evaluations, toxicology studies, and GLP-compliant research documentation. Experienced in authoring and reviewing scientific reports, technical documentation, literature reviews, research protocols, manuscripts, and regulatory submissions aligned with OECD, ISO 10993, and GLP requirements. Passionate about transforming complex scientific data into clear, accurate, and publication-ready scientific communication. Currently seeking opportunities in Scientific Writing, Regulatory Affairs, Research Documentation, Toxicology and Medical Device Research.

Location

Bengaluru

Work experience

Research Assistant - Study Director at Accuprec Research Labs Pvt. Ltd., Dec 2024 - Jun 2025 · 7 mos, Led end-to-end documentation for GLP-compliant in vitro toxicology studies supporting medical device safety evaluations. Authored and finalized study protocols, technical reports, and final summaries aligned with regulatory expectations. Translated complex raw experimental data into structured scientific narratives, tables, and defensible conclusions for cytotoxicity, hemolysis, Ames, and genotoxicity studies. Served as Study Director, ensuring data integrity, documentation accuracy, traceability, and audit readiness across all study phases. Developed and maintained SOPs, internal documentation, and standardized report templates to strengthen compliance and consistency. Collaborated cross-functionally with scientific and quality teams to deliver precise, regulatory-facing documentation for sponsors, auditors, and reviewers.

Research Assistant - Study Personnel at Accuprec Research Labs Pvt. Ltd., Dec 2022 - Dec 2024 · 2 yrs 1 mo, Supported the Study Director across all phases of GLP-compliant in vitro toxicology studies, from protocol development to final reporting. Managed phase-specific documentation, raw data records, deviations, and amendments in alignment with GLP requirements. Prepared audit and regulatory submission documents (OECD, ISO 10993), ensuring accuracy and traceability. Maintained laboratory compliance through documentation control, equipment records, and data integrity practices, ensuring continuous audit readiness.

Intern at NEUBERG SUPRATECH REFERENCE LABORATORIES, Oct 2022 - Dec 2022 · 3 mos, Ahmedabad, Gujarat, India, done Internship at Neuberg Supratech reference laboratory - Genomic medicine sponsored by Gujarat biotechnology Research Centre - Industrial Biotechnology Training Program In this training program, I spent 1 week for each department to know the overview of techniques.

Education

Master's degree, Microbiology, General, Institute of Advanced Research, Gandhinagar

Bachelor of Science - BS, Microbiology, General, Lj institute of applied science

Ditiksha Mandanka - Research Assistant - Study Director in Bengaluru | Tal