Global Regulatory Compliance

We comply with all global and local regulatory frameworks, including:

• FDA (U.S.) – 21 CFR Part 11 (electronic records & signatures), CDISC standards (Clinical Data Interchange Standards Consortium)
• EMA (Europe) – Good Clinical Practice (GCP), GDPR for data privacy
• ICH-GCP – International guidelines ensuring ethical and scientific quality
• MHRA (UK) – Compliance with EU and UK-specific clinical trial regulations
• HIPAA (U.S.) – If handling patient health data

How WEP Manages Regulatory Submission

• CDISC Standards (SDTM & ADaM) – Format data to meet regulatory submission requirements
• 21 CFR Part 11 Compliance – Ensure electronic records meet FDA validation standards
• Clinical Study Reports (CSRs) & Statistical Reports – Prepare detailed regulatory documentation
• Regulatory Queries & Responses – Support Sponsors in addressing questions from health authorities

WEP Ensures

• Compliance with regional regulations (e.g., CDISC standards for FDA)
• Correct data formats (eCTD sequence numbers, metadata tagging)
• SAS Data Extractions per FDA submission guidance
• Error-free submission using validation tools (eCTD validators)