Regulatory Affairs

Upholding the Highest Standards of Compliance

Geneva’s regulatory teams develop robust regulatory strategies early in the development process to ensure alignment with project objectives and milestones. By proactively identifying potential challenges and managing risks, the team facilitates seamless navigation of regulatory complexities in collaboration with relevant authorities.

Key Capabilities:

 

    • Development, submission, compliance, and ongoing documentation of regulatory packages, including IRB/IACUC review and approval, managed by dedicated regulatory staff.
    • Adherence to FDA regulations and Good Clinical Practices (GCPs) to uphold the highest standards of compliance.