Protocol, IB, IMPD, and ICF Development

Precision in Regulatory Documentation
Statim Ltd specializes in the development of critical regulatory documents required for drug approval processes. Our expertise ensures that your Protocol, Investigator’s Brochure (IB), Investigational Medicinal Product Dossier (IMPD), and Informed Consent Form (ICF) are crafted with precision and in full compliance with EMA and MHRA guidelines.

Our Documentation Services:

  • Protocol Development: Creating detailed study protocols that meet regulatory requirements and support successful trial outcomes.
  • Investigator’s Brochure (IB): Comprehensive preparation of IBs to provide essential information on your investigational product.
  • IMPD Development: Ensuring your IMPD meets all regulatory standards for submission to the EMA and MHRA.
  • Informed Consent Forms (ICF): Developing clear and compliant ICFs to protect patient rights and support trial integrity.
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