i. Interpretation of toxicology findings including histopathology
ii. Evaluation and integration of toxicokinetic results into the overall toxicology data package
iii. Study Audit and Monitoring
iv. GLP/Non GLP Study Plan/Protocol review and preparation
v. SOP, STP writing and method validation
i. Assessing safe and allowable levels and qualification of process impurities, residual solvents, degradants, and excipients
ii. Quantitative Structure-Activity Relationship (QSAR) analysis
iii. Permitted Daily Exposure (PDE) Calculations
iv. Acceptable Daily Exposure (ADE) Calculations
v. Occupational Exposure Limit (OEL) Calculations
vi. Toxicological risk assessment of Pharmaceutical, Cosmetics, Medical Devices, chemical and Consumer products
i. Due Diligence Audit
1. CRO Selection, Study placement & Monitoring
2. Pathology Peer Review services
3. Toxicology and Pathology data and report review
ii. GLP Audit Services
1. GLP Compliance & Adequacy assessment
2. Study, Process and Facility Audits
3. GLP Process improvement and gap analysis
4. NGCMA inspection readiness
5. Audit report preparation and services
iii. CPCSEA Audit Services
i. OECD- GLP principal training
ii. CPCSEA- Guideline& compliance training
iii. Employee training and competency Evaluation (Compliance Master) on GLP, Toxicology and Pathology
i. Manage PreClincal Phase
ii. Manage Bio Analytical Studies
iii. CRO Identification and study management
iv. Archives Management
v. Animal House Management