TRD Consulting

TRD Consulting - Innovative Toxicology

🧪 Strategic IND/NDA/ANDA(Generics)/BLA Regulatory Submission Consulting

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

Are you preparing an IND, NDA, ANDA, or BLA submission for regulatory approval in the US, EU, or other international markets? Gain a strategic advantage with expert consulting from Dr. Ramesh Subramani, a globally recognized Regulatory Toxicologist with over two decades of global experience in nonclinical development and global regulatory submissions.

Dr. Subramani provides customized, science-driven, and regulation-compliant support to help pharmaceutical and biotechnology companies achieve successful preclinical regulatory submissions. His expertise bridges toxicology, safety pharmacology, GLP compliance, and dossier documentation, tailored to meet evolving requirements of US FDA, EMA, MHRA, BfArM, Health Canada, ANVISA, DCGI and emerging markets..

🧬 Regulatory Submission Services Include:

✅ Strategic planning for IND, NDA, ANDA, and BLA filings

✅ Toxicology gap analysis and data readiness assessment

✅ Preparation and review of Nonclinical regulatory sections

✅ Study design consulting for ICH , OECD, EMA, FDA and other guidances

✅ Integrated safety summaries and justification writing

✅ Support for pre-submission meetings with regulatory authorities

✅ Regulatory responses and deficiency remediation

✅ Safety assessments for impurities and excipients

✅ My Credentials?

01 Certified Toxicologist

02 Regulatory experience with US FDA, EMA, BfArM, MHRA, Health Canada, ANVISA and emerging markets

03 Deep knowledge of ICH, OECD, EMA, US-FDA, BfArM, MHRA, Health Canada, and WHO guidelines

04 Hands-on experience with IND enabling studies and safety dossiers

05 Former Senior Toxicologist (SME) at Eurofins, Dr. Reddy’s Lab, Vivo BioTech and BSL Bioservice

🌍 Supporting Global Drug Development

📧 Contact Today

Remote and on-site consultation services available for Pharma, Biotech, Medical Devices and Chemicals. Pre-Clinical CROs across North America, Europe, Canada, Japan and Asia-Pacific.

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

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