ADE/PDE/OEL & OEB Calculation for Cleaning Validation
Expert ADE, PDE, OEL, and OEB calculations for pharmaceutical cleaning validation that ensure patient safety and prevent cross-contamination in shared manufacturing facilities.
Comprehensive ADE/PDE/OEL Calculation Report
Scientific Justification with Detailed Methodology
Toxicological Monograph and Safety Summary
Risk Assessment Report for Cleaning Validation Protocols
Genotoxic Impurity & Medical Device Toxicology Assessment
Expert CRO services for comprehensive genotoxic impurity evaluation and medical device toxicological risk assessments. Ensuring regulatory compliance and patient safety.
Comprehensive genotoxicity risk assessment report fully aligned with ICH Q3A/B/C/M7 guidelines
Evidence-based TTC impurity categorization and strategic qualification approach
Detailed Toxicological Risk Assessment (TRA) report for medical devices per ISO 10993 standards
Professional assessment of extractables and leachables (E&L) with regulatory interpretation
Global Regulatory Compliance & Medical Device Registration
Navigate global markets with ease. We offer expert guidance on CTD/ACTD dossiers, medical device submissions, CEP/DMF filings, and act as your official regulatory representative.
Comprehensive GRAS evaluation services and CPSR preparation for FDA and EMA compliance in non-pharmaceutical industries, ensuring your products meet global safety standards.
GRAS Self-Affirmation or FDA Notification Dossier
Cosmetic Product Safety Report (CPSR) for EU/UK markets
Safety assessment documentation and expert evaluations
Regulatory compliance strategy and submission support
Quality Assurance Services for BA/BE Studies & Related Fields
Independent QA oversight for BA/BE, pre-clinical, and clinical studies to ensure compliance, protect data integrity, and prepare for regulatory success.
