TRD Consulting

TRD Consulting - Innovative Toxicology

🔬 Nonclinical Safety Studies Consulting Services

Design & Monitoring of In Vitro and In Vivo Toxicology Studies by Dr. Ramesh Subramani

Maximize the success of your drug development or chemical registration program with expert-led nonclinical safety study design and monitoring services. Dr. Ramesh Subramani, a certified toxicologist with over two decades of global regulatory experience, offers tailored consulting for GLP-compliant in vitro and in vivo studies aligned with international regulatory expectations.

Whether you're preparing for an Investigational New Drug (IND) submission or evaluating the safety of a chemical or medical device, Dr. Subramani ensures your toxicology studies are strategically designed, scientifically robust, and fully compliant with global regulatory requirements.

✅ Expert Services in Nonclinical Study Design & Monitoring

In Vitro Study Design & Oversight :

Dr. Subramani provides expert guidance on the planning and interpretation of non-animal toxicology assays, including:

Genotoxicity assays (Ames test/EAT, micronucleus, chromosomal aberration and other batteries)
Cytotoxicity and cell viability assays
Mechanistic and mode-of-action studies
In vitro irritation/corrosion and sensitization models (OECD TGs)
In vitro DMPK assays such as Metabolic stability and CYP450 induction/inhibition studies
Safety pharmacology in vitro assays (CiPA)
NAMs assays

🐁 In Vivo Toxicology Study Design & Monitoring :

Strategic planning and monitoring of animal studies under GLP and OECD guidelines, including:

Acute, sub-acute, sub-chronic, and chronic toxicity studies
Reproductive and developmental toxicity (DART)
Carcinogenicity and immunotoxicity/immunogenicity
Safety pharmacology (CNS, cardiovascular, respiratory and others)
DMPK - PK/TK and dose-range finding studies
Efficacy/Pharmacology studies
Neurotoxicity and Genotoxicity (batteries) studies
Local Tolerance and Phototoxicity studies

🌍 All my services Regulatory Alignment for Global Submissions are aligned with:

01 ICH guidelines for pharmaceuticals

02 OECD test guidelines for chemicals

03 Regional agency expectations: FDA, DCGI, EMA, MHRA, ECHA, EFSA, BfArM, ANVISA, Japan and more

🎯 Benefits of Working with Dr. Ramesh Subramani

DABT/ERT-certified regulatory toxicologist with global experience
Experience with Eurofins,Vivo Bio Tech, Dr. Reddy’s Lab and BSL Bioservice
Proven track record of nonclinical support for IND/NDA/ANDA/BLA submissions
Efficient study planning to reduce costs and development timelines
End-to-end oversight – from study protocol design to data interpretation and reporting

🚀 Ready to Plan Your Next Nonclinical Study?

Partner with a recognized expert in regulatory toxicology to optimize your preclinical development program and ensure successful regulatory outcomes.

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

Study Designing and Monitoring of Nonclinical Safety and Pharmacology Studies (in vitro and in vivo)