FAQ's

I design and monitor studies in accordance with OECD, ICH, ISO and GLP guidelines, ensuring scientific robustness and regulatory acceptance for pharmaceutical, chemical, and device safety evaluations.

PDE (Permissible Daily Exposure) and OELs (Occupational Exposure Limits) are critical safety thresholds derived from toxicological data to protect human health by limiting exposure to potentially harmful substances during drug use or workplace handling.

Quantitative Structure-Activity Relationship (QSAR) models predict chemical toxicity based on molecular structure, helping assess safety profiles without extensive animal testing, supporting faster risk evaluations.

I provide expert evaluation of E&L data from packaging, manufacturing materials, and medical devices to identify potential toxicological risks and ensure patient safety under regulatory expectations.

I help identify, assess, and set safety limits for impurities and genotoxic compounds in pharmaceuticals, using toxicology data and regulatory guidelines to support drug approval and risk management.

I offer customized advisory services to develop SOPs, staff training, audit preparation, and corrective action plans ensuring full GLP compliance for reliable and regulatory-accepted study data

Ensuring comprehensive nonclinical data packages that meet global regulatory expectations is complex; I help navigate these challenges through strategic planning, data gap analysis, and dossier compilation.

I incorporate ethical principles such as the 3Rs (Replacement, Reduction, Refinement) into study protocols to minimize animal use while maintaining data quality and regulatory compliance.

I have extensive experience working with agencies such as the US FDA, EMA, ECHA, EFSA, DCGI, MHRA, BfArM, ANVISA, Health Canada, Japan and emerging market regulators, ensuring compliance with diverse regulatory landscapes.

Absolutely. I tailor consulting services to fit the budget and scale of startups while providing critical guidance on regulatory pathways, study designs, and safety assessments.

I actively participate in professional organizations like the American Board of Toxicology, American College of Toxicology, EUROTOX, Regulatory Affairs, Pathology and Teratology Societies, Safety Pharmacology, Royal Society of Biology and British Toxicology Society, attending conferences, webinars, presentations, continuing education (CE) courses and continuously review new guidelines and scientific literature.

Common pitfalls include insufficient study design, poor data quality, and regulatory non-compliance. I mitigate these risks through expert protocol review, monitoring, and targeted recommendations

Timeline varies by project complexity; however, with early planning and expert guidance, I help clients streamline processes to meet critical submission deadlines efficiently.

Typically, I require study protocols, previous toxicology reports, regulatory requirements, and any preliminary data to tailor consulting services effectively.

All client information is handled with strict confidentiality agreements to protect intellectual property and comply with legal and ethical standards.

Yes, I assist in thorough data analysis, interpretation, and preparation of responses to regulatory queries to facilitate smoother review and approvals.

You can reach out via email at ramesh@trdconsultings.com or submit your inquiry through the contact form on www.trdconsultings.com to arrange an initial consultation.