ramesh@trdconsultings.com

Tel : +49 89 38048726

D-82061, Munich, Germany

Value Proposition

Value Proposition

Expert Regulatory Toxicologist Offering End-to-End Drug Safety and Nonclinical Development Consulting

Dr. Ramesh Subramani brings over two decades of international experience in nonclinical drug discovery and development, toxicology consulting, chemical safety assessment and regulatory strategy for pharmaceutical, biotech, medial device and chemical industries.

As an independent toxicology consultant, Dr. Subramani provides expert guidance in designing and reviewing preclinical studies, ensuring regulatory compliance, risk-based toxicological evaluations, and strategic dossier support for global market authorizations.

🔬 Services Tailored for Global Drug Development and Chemical Safety Evaluation

✅ Drug Discovery and Development Consulting

Providing scientific and regulatory insights to support early-stage compound selection, lead optimization, and IND-enabling studies.

✅ Toxicology Study Design and Review

Expert design, review, and interpretation of GLP-compliant in vitro and in vivo toxicology studies, reducing risk and enhancing data quality.

✅ Regulatory Strategy and Nonclinical Planning

Strategic nonclinical development roadmaps for IND, NDA, BLA, and international regulatory filings (US FDA, EMA, DCGI, ECHA, EFSA, MHRA, BfArM, ANVISA, Japan and more).

✅ GLP Compliance and Quality System Implementation

In-depth support for setting up or optimizing Good Laboratory Practice (GLP) systems in accordance with OECD principles of GLP for the regulatory toxicology studies.

✅ Toxicological Risk Assessments and Safety Threshold Determination

Comprehensive safety evaluations including PDE (Permitted Daily Exposure), OEL (Occupational Exposure Limits), E&L (Extractables & Leachables), ERA (Environmental Risk Assessment), Nitrosamines (NDSRIs), QSAR-based predictions (ICHM7), Carcinogenicity, and genotoxic impurity assessments.

✅ Impurity Safety and Qualification

Scientific justification and qualification of impurities, degradants, and excipients in compliance with global regulatory expectations

✅ Regulatory Dossier Support

Detailed data analysis, risk assessments, and expert summaries for inclusion in CTD modules for regulatory submissions across markets.

🌍 Professional Recognition & Memberships

I am :


01


A Diplomate of the American Board of Toxicology (DABT)

02


A member of the Indian Society of Toxicopathology (STPI), India

03


A member of the European Registered Toxicologist (EUROTOX), Switzerland

04


A member of the Regulatory Affairs Professional Society (RAPS), USA

05


A member of the British Toxicology Society (BTS), UK

06


A member of the Royal Society of Biology (RSB), UK

07


A member of the Safety Pharmacology Society (SPS), USA

08


A member of the European Teratology Society (ETS), Switzerland

09


A member of the Regulatory Representatives & Managers Association (RRMA), India

10


A member of the American College of Toxicology (ACT), USA

 

His global experience and affiliations ensure current, science-based, and compliant strategies for your drug/chemical safety programs.

🧠 Who Benefits from my consulting services:

  • Pharmaceutical, biotech, medical device and chemical companies requiring toxicology safety/risk assessments and regulatory strategy
  • CROs seeking expert oversight for GLP study and compliance
  • Regulatory affairs teams preparing for global submissions including IND, NDA, ANDA, BLA and more
  • Chemical manufacturers requiring safety evaluations for REACH or EPA compliance
  • CDMO and GMP Facilities

Get in touch for a customised regulatory toxicology consulting plan tailored to your molecule and target market.

Call now

+49 89 38048726

E-Mail Address

ramesh@trdconsultings.com