Regulatory Support

We provide expert guidance to help research teams and organizations navigate the complex landscape of clinical research regulations. From protocol submissions to ethics approvals and compliance with local and international standards (ICH-GCP, FDA, EMA), our regulatory support services ensure your studies meet all necessary requirements. We streamline documentation, submissions, and communication with oversight bodies so you can focus on conducting impactful research with confidence.

We provide the following products…

Ethics & Regulatory Submission Support

  • Description: Assistance in preparing and submitting protocols, informed consent forms, and supporting documents to Institutional Review Boards (IRBs)/Ethics Committees and regulatory authorities.

  • Format: Project-based support until approval.

  • Pricing Plans:

    • Starter – $500/project
      Basic document review & submission guidance.

    • Pro – $1,200/project
      Full protocol and consent package preparation with submission support.

    • Premium – $2,500+/project
      Comprehensive submission service including regulatory correspondence.

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Compliance Documentation & Audit Readiness

  • Description: Development and review of essential regulatory documents (SOPs, Investigator Brochures, Trial Master Files) and preparation for audits/inspections.

  • Format: Package tailored to project phase.

  • Pricing Plans:

    • Starter – $400/project
      Basic document review and compliance checklist.

    • Pro – $1,000/project
      SOP development and essential regulatory documentation package.

    • Premium – $2,000+/project
      Full audit-readiness support including mock inspection and corrective action plan.

Ongoing Regulatory Advisory

  • Description: Continuous guidance on evolving regulations, amendments, and compliance strategies throughout the study lifecycle.

  • Format: Subscription or retainer model.

  • Pricing Plans:

    • Starter – $300/month
      Monthly check-ins and regulatory updates.

    • Pro – $750/month
      Bi-weekly advisory with document reviews.

    • Premium – $1,500+/month
      Full retainer with on-demand consultation and regulatory support.