TRD Consulting - Innovative Toxicology

Regulatory Toxicology


Expert Regulatory Toxicology Services for Pharmaceutical, Biotech and Chemical Industries

TRD Consulting - Innovative Toxicology

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

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

TRD Consulting - Innovative Toxicology

Toxicology Risk Assessment Consulting


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

TRD Consulting - Innovative Toxicology

GLP Implementation and Compliance Advisory

Good Laboratory Practice (GLP) Consulting by Dr. Ramesh Subramani

TRD Consulting - Innovative Toxicology

Strategic IND/NDA/ANDA/BLA Support for Global Regulatory Submissions

End-to-End Regulatory Toxicology Support by Dr. Ramesh Subramani

TRD Consulting - Innovative Toxicology

Animal Welfare and Ethical Study Design Guidance

Humane, Regulatory-Compliant Preclinical Study Design by Dr. Ramesh Subramani

TRD Consulting - Innovative Toxicology

Dr. Ramesh Subramani, DVM, DABT, ERT, RAC, DSP

– Expert Regulatory Toxicology Consultant

Welcome to TRD Consulting – your trusted partner in regulatory toxicology and nonclinical drug development and chemical safety.

I’m Dr. Ramesh Subramani, US board-certified and European Registered Toxicologist, an Independent Toxicology Consultant and Regulatory Toxicologist with over two decades of global experience in the pharmaceutical, biotech, and chemical industries. As a qualified Veterinarian (DVM) and a certified regulatory toxicologist (DABT, ERT, UKRT, RAC (US), DSP), I bring in-depth scientific, regulatory, and strategic expertise to support your toxicological evaluations of pharmaceuticals, medical devices and chemicals.

Our Services


Consulting Services

TRD Consulting is a global nonclinical consulting firm delivering high-quality toxicology and pharmacology services to the pharmaceutical, biotech, medical device, and chemical industries. Leveraging expertise in Toxicological Research and Development (TRD), We specialize in Drug Discovery, New Drug Development (IND/NDA/BLA), Generic Drug Development, 505(b)(2) Formulations, Toxicology Evaluation and Risk Assessment, Safety Assessment of Chemicals.

As an independent regulatory toxicologist and Nonclinical consulting firm, our primary focus is to provide technical and regulatory support for both new and existing products. We pride ourselves on delivering expertise that is effective, flexible, reliable, and timely—helping clients navigate complex regulatory pathways with confidence and compliance.

why choose TRD Consulting

Who Benefits from my consulting services

Pharmaceutical, biotech 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

20+

Years Experience

1000+

Projects Completed

100+

Customers

5+

Certifications

TRD Consulting

Value Proposition


🔬 Services Tailored for Global Drug Development and Chemical Safety

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, and more).

Impurity Safety and Qualification

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

Testimonials

Our customers are saying

"It was a great pleasure to work with Ramesh. I have to point out his excellent skills in managing nonclinical small and large complex multi-site in vivo studies. His thorough knowledge of toxicology combined with his pro-active and constructive character and well-organized nature enabled him to design, plan and execute the studies according to rigid timelines and to utmost success. He followed a culture of transparency regularly updating clients about their studies. His vast experience allowed him to share his thoughts about results and discuss with the clients freely and constructively. Ramesh is a quick learner and constantly seeks to broaden his knowledge on the toxicological field. As a senior member of our group, he was always a strong mentor with an urge to share his skills in a supportive and team-oriented way."

- Head of Toxicology

Preclinical GLP Lab, Germany

"As a clinical consultant working across diverse drug development programs, I’ve had the privilege of collaborating with Ramesh Subramani, whose expertise in toxicology and preclinical strategy has consistently elevated the quality and efficiency of our projects. I highly value his scientific rigour, nonclinical regulatory expertise, and collaborative mindset, which make him a trusted partner in the drug development process."

- Clinical Consultant

Netherlands

"We have been working with Dr. Ramesh as a toxicology consultant for our GLP-certified laboratory projects. His expertise, reliability, and solution-oriented approach have significantly contributed to the development and international positioning of our laboratory. We value his scientific integrity and timely support across all phases of our work."

- CEO, Preclinical GLP Lab

Istanbul

"Your expertise and thorough approach have been invaluable in ensuring the safety and regulatory compliance of our products. Your insights and attention to detail consistently contribute to the success of our projects."

- Global Head of Clinical Affairs

Spain

"I am happy to share with you the good news of our product getting US FDA approval. The work we initiated to support qualification of impurities at higher levels was critical to our success. Your diligence to ensure the Tox studies were conducted according to Agency requirements and your inputs in the study report presentation is appreciated by our team very much"

- Chief Scientific Officer

USA

I am delighted to share our experience working with Dr. Ramesh Subramani. His exceptional expertise and support have been key to the success of our phase 3 enabling animal GLP-compliant toxicology studies. Dr. Subramani's strong background as a board-certified toxicologist and regulatory affairs professional was evident throughout the project. His strategic planning and technical knowledge ensured that every aspect of the study met the highest scientific and regulatory standards.
Dr. Subramani helped us to anticipate potential challenges and provided clear, practical advice that improved the quality and efficiency of the study. His proactive communication with our team and other stakeholders ensured smooth coordination from study design and monitoring to the final reporting stages. His guidance has also been crucial in aligning the study results with our broader regulatory goals.
Dr. Subramani's professionalism, dedication, and teamwork set a high standard. He exceeded expectations by becoming a trusted advisor and playing a pivotal role in the success of the project. I strongly recommend Dr. Subramani to any organization looking for an expert who consistently delivers excellent results in toxicology and regulatory science.

Executive Chairman and CEO

Spain

"I am happy to confirm that there were no questions from the regulatory authority regarding the tox assessment report which you have provided to justify the safety at GMP facility and that they have granted the authorization immediately. Thank you again for all your support!"

- Quality Assurance Operations, Director

Italy

If you any questions or need help contact with team. +49 89 38048726

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