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Regulatory Submission, Approval & Compliance Strategy

We navigate global regulatory landscapes with confidence, helping you prepare, submit, and maintain full compliance throughout early development.

Submission Strategy & Preparation

 

IND, CTA, and scientific advice meeting preparation (FDA/EMA/MHRA).

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  • Alignment of protocol and documentation to regulatory expectations.

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Compliance Integration

  • GxP and ICH E6(R3) adherence from trial design to execution.

  • Ethics committee and IRB submission support.

 

Inspection Readiness & Audit Support

  • Pre-inspection audits and CAPA implementation.

  • Documented evidence trails via cintl.ai for 21 CFR Part 11/Annex 11 compliance.

 

Outcome       Smooth, efficient regulatory approvals and inspection-ready documentation that strengthens trust                           with authorities and partners.

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