Investigator’s Brochures (IB)

We understand the demanding timelines for clinical development; we will ensure that the (IB) we prepare is a comprehensive document summarizing the safety measures of a clinical trial protocol, such as Dose, Frequency of dosing interval, Methods of administration and Safety monitoring procedures.

Our Expertise

• Generate a High-Level IB under ICH E6 Guideline for Good Clinical Practice
• Investigational Medicinal Product Dossiers (IMPDs)
• Intelligence in Posology Studies
• Safety Evaluation and Regulatory Support for Extractable and Leachable
• Biocompatibility Safety Assessment of Medical Devices