Regulatory Toxicology Services

✅ Nonclinical Study Design & Review

Strategically planned GLP-compliant in vitro and in vivo studies, reviewed and interpreted by an experienced toxicology consultant to support IND, NDA, ANDA (Generics), and BLA submissions

✅ Regulatory Strategy & Risk-Based Planning

Comprehensive regulatory strategies tailored for US FDA, EMA, MHRA, BfArM, ANVISA, and global markets

✅ GLP Compliance Consulting

Ensure regulatory readiness with expert guidance on OECD GLP principles, implementation, audits, corrective and preventive action (CAPA) for CROs and Sponsors

✅ Toxicological Risk Assessments

Detailed risk assessments for pharmaceuticals, chemicals, and medical devices, including:

✅ Impurity Safety Evaluation and Qualification

Toxicological justification and qualification of organic and inorganic impurities, degradants, residual solvents, and excipients in line with ICH M7, Q3A/B, and other relevant guidelines

✅ Regulatory Dossier Support

Authoritative review and expert summaries for Module 4 (Nonclinical Study Reports) and Module 2.4/2.6 (Nonclinical Summaries) of the Common Technical Document (CTD) format

✅ Safety Assessment of Chemicals

Safety Assessment of Chemicals, Biocides, Nutraceuticals and Food additives/supplements (OECD Testing of Chemicals)

✅ Analytical (dose formulation and bioanalytical) support for toxicology studies

✅ Writing and reviewing of Toxicology sections for regulatory submissions

✅ Preparation of Investigator’s Brochure and IMPD