At Clinova CRO, we provide comprehensive regulatory support to ensure clinical trials meet global compliance standards. Our expert team assists with:

• Regulatory Strategy Development – Crafting tailored regulatory pathways for drug and device approvals.
• Submission Preparation & Filing – Managing documentation for regulatory agencies, including FDA, EMA, and local authorities.
• Compliance & Quality Assurance – Ensuring adherence to Good Clinical Practice (GCP) and international regulatory guidelines.
• Ethics Committee & Institutional Review Board (IRB) Coordination – Facilitating approvals and maintaining ethical standards.
• Post-Approval Regulatory Support – Handling ongoing compliance, reporting, and market authorization requirements.