Regulatory-Grade Evidence
Our regulatory-grade data ensures your submissions meet compliance standards and postmarket safety requirements. Rely on us for the evidence that supports your approvals.
Data Assessment & Studies
- Fit-for-purpose Data Assessment: Ensure your data is reliable and ready for regulatory submissions with our rigorous evaluations, incorporating Real-World Evidence where applicable.
- Observational Studies for Regulatory Approval: Use Real-World Evidence to meet regulatory requirements and strengthen your product’s approval case.
- Postmarket Safety Monitoring: Track and evaluate product safety after launch using Real-World Data to stay compliant and address safety concerns swiftly.
Documentation & Reporting
- Technical Documentation: We create comprehensive technical documents that meet the highest standards for regulatory submissions, incorporating Real-World Data when needed.
- Data Source Justification: Provide clear, compliant justifications for data sources, including Real-World Evidence.
- Pharmacokinetics Reports: Generate detailed reports on absorption, distribution, metabolism, and excretion to support your product’s regulatory submissions.
Jim Baker
Business Development
Executive
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