Regulatory Affairs & Compliance
Navigating the complex landscape of clinical trial regulations is critical for success. Our Regulatory Affairs & Compliance team provides end-to-end support to ensure your studies adhere to FDA, EMA, ICH-GCP, and local requirements. From protocol design to final approval, we mitigate risks, streamline submissions, and keep your trials audit-ready.
Key Services:
- Regulatory Strategy & Submissions – Expedited IND/CTA filings and agency communications.
- Compliance Audits & Gap Assessments – Identify and resolve deviations proactively.
- Documentation & SOPs – Maintain trial master files (TMF) and inspection-ready records.
- Ethics Committee & IRB Liaison – Secure approvals and address regulatory queries.
- Post-Marketing Surveillance – Ensure ongoing compliance with pharmacovigilance requirements.