Toxicology | Pathology | Regulatory | Compliance | Training | Services


Pre-clinical/ non-clinical Services

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

Risk Assessment and Regulatory Services

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

Audits and Compliance Services

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

Training Services

i. OECD- GLP principal training

ii. CPCSEA- Guideline& compliance training

iii. Employee training and competency Evaluation (Compliance Master) on GLP, Toxicology and Pathology

Project Managemen

i. Manage PreClincal Phase

ii. Manage Bio Analytical Studies

iii. CRO Identification and study management

iv. Archives Management

v. Animal House Management

Compliance Master

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