Regulatory Support
We help clients navigate complex regulatory requirements to ensure smooth clinical trials and product development. Our services include:
- Preparation and submission of regulatory dossiers (CTIS)
- Local hospital board approvals and contracting
- Early product development advice and regulatory strategy consulting
- Management of study amendments, protocol modifications, and study termination
Expert advice on early product development strategies for medicinal products, veterinary products, medical devices, cosmetics, and food supplements
Quality Assurance (QA)
Our QA team ensures compliance and high standards across all projects:
- Conducting audits of clinical sites, vendors, and internal processes
- Monitoring adherence to GCP, GMP, and GDP guidelines
- Developing and reviewing SOPs, protocols, and documentation
- Providing corrective and preventive action support
In addition, we provide Quality Control services to support QA and ensure data accuracy and process integrity:
- Verification and control of data in eCRFs and clinical trial databases
- Validation of processes and systems used in clinical trials
- Identification and correction of errors before data submission for analysis
- Reporting non-conformities and supporting their timely resolution
We offer comprehensive regulatory, QA, and QC services, ensuring compliance, efficiency, and reliability at every stage of your project.