TRD Consulting

About 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.

🌐 What I Do

As an expert in regulatory toxicology and GLP compliance consulting, I provide tailored, science-driven solutions for companies navigating the complex landscape of global drug and chemical safety regulations.

Core Areas of Expertise

✅ Regulatory Toxicology Services for Pharmaceuticals, Biotech, Medical Devices and Chemicals

✅ Toxicology Risk Assessment Consulting – Including PDE, OELs, QSAR, E&L, ERA and Genotoxicity/Carcinogenicity Evaluation

✅ GLP Implementation and Compliance Advisory

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

Global Regulatory Experience

Throughout my career, I have supported nonclinical development programs for submissions to leading regulatory authorities including:

01 US FDA, EMA (Europe), MHRA (UK), BfArM (Germany)

02 Health Canada, ANVISA (Brazil), and other emerging markets

03 DCGI (India), ECHA, EFSA, Turkey and Japan

I have successfully collaborated with reputed CROs and pharmaceutical companies such as Eurofins (Advinus/Adgyl), Vivo Bio Tech, Dr. Reddy’s Laboratories, and BSL Bioservice, Munich. I have served in critical roles such as Senior Toxicologist (SME) and Study Director, ensuring the design, study conduct, data review, and reporting of GLP compliant high-quality toxicology studies.

🧪 Why Partner with TRD Consulting?

When you engage with TRD Consulting, you gain a deeply knowledgeable toxicology strategist who understands the regulatory expectations, scientific rigor, and business pressures of today’s life sciences industry. Whether you're a start-up seeking IND-enabling studies or an established pharma company requiring toxicological risk assessments for global submissions, I offer end-to-end support backed by two decades of hands-on expertise including chemical safety assessments as per OECD testing of chemicals requirements and safety assessment of pharmaceuticals/ medical devices.

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

📦 Services Offered at a Glance

💊 Drug Discovery Consulting

🧩 Regulatory Toxicology Study Design & Expert Review

🔄 Regulatory Strategy & Nonclinical Development Planning

🔐 Study Monitoring and Expert Advice

📊 GLP Compliance & Implementation Consulting

⚕️ Toxicological Risk Assessments (PDE, OEL, E&L, ERA, Genotoxicity, Carcinogenicity and more)

🧬 Impurity Qualification

🧪 Safety Assessments of drugs/chemicals

🔬 Regulatory Dossier Support for IND, NDA, BLA, and more

🧑‍💼 How do I work with my clients?

01 Ad hoc

Ad Hoc consulting is provided on a temporary or as-needed basis, typically for a specific project or problem. Ad hoc consulting is more focused and limited in scope. Fixed hourly rate.

02 Short & Long Term Projects

Our short and long-term consulting service refers to a type of engagement that is of a specific duration, typically ranging from a few days to up to a year or more for studies. It is designed to provide targeted assistance to clients who have specific needs or objectives

Fixed hourly rate, per weekly or bi-weekly or monthly billing.

03 Fixed Price

Fixed price consulting services are provided at a predetermined, fixed cost. In this arrangement, the consultant and the client agree on a specific fee for the entire consulting engagement, regardless of the actual time or effort required to complete the project. The client knows the exact cost of consulting the project upfront, which helps with budgeting and financial planning. Billed monthly.

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