TRD Consulting

TRD Consulting - Innovative Toxicology

🧪 Toxicology Risk Assessment Consulting

PDE, OEL, QSAR, E&L, ERA, Carcinogenicity and Genotoxic Impurity Evaluation Services by Dr. Ramesh Subramani

Looking for expert toxicological risk assessment (TRA) consulting? Dr. Ramesh Subramani, a certified regulatory toxicologist, offers end-to-end risk evaluation services that comply with ICH, EMA, US FDA, and other global regulatory guidelines. With overover two decades of global experience, Dr. Subramani delivers precise and science-driven guidance for pharmaceutical, biotech, and medical device safety evaluations.

🔬 Specializations Include:

✅ PDE (Permitted Daily Exposure) Calculations – For cleaning validation and cross-contamination risk

✅ Occupational Exposure Limits (OELs) – Hazard banding and worker safety assessments

✅ QSAR (Quantitative Structure-Activity Relationship) – Computational toxicology for early risk flagging

✅ Extractables & Leachables (E&L) Evaluation – Material compatibility and safety for medical devices

✅ Genotoxic Impurity Assessment – Threshold of Toxicological Concern (TTC), Mutagenicity, Carcinogenicity and safety limits

✅ Nitrosamines Safety Assessment (NDSRIs) - in vitro and in vivo genotoxicity assessment and CPCA

Whether you're preparing a regulatory dossier (IND, NDA, ANDA( Generics), BLA) or supporting CMC and product lifecycle decisions, Dr. Ramesh’s deep expertise ensures your toxicological justifications are accepted by global agencies including US FDA, DCGI, EMA, MHRA, BfArM, Health Canada, and ANVISA.

🎯 Why Work with Dr. Ramesh Subramani?

01 DABT certified (Diplomate of the American Board of Toxicology)

02 ERT Certified (UK and European Registered Toxicologist)

03 RAC (Regulatory Certified Professionals) – US FDA

04 Member of British Toxicology Society, Royal Society of Biology, and Safety Pharmacology Society

05 Proven success in Nonclinical and CMC risk evaluation

06 Strong background in regulatory submissions and scientific defence

07 Former senior Toxicologist (SME) at Eurofins (Advinus/Adgyl), Dr. Reddy’s Laboratories and BSL Bioservice (Germany)

📧 Contact Today

Get in touch for a customised toxicology risk assessment plan tailored to your product and target market.

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