Whatever problem or situation you encounter, we are here to assist you:

Our consultants can:

  • assist Sponsors/CRO/Sites with SOP writing and/or review;
  • guide you through country-specific regulatory pathways for clinical trials (drugs), clinical investigations (devices) or performance evaluations (in vitro diagnostics);
  • provide information on country-specific submission requirements;
  • assist in compiling your Medical Need Program documentation;
  • organize trainings for Sites/your staff/your management;
  • do ICH-GCP audits, quality checks, TMF review;
  • etc.


Feel free to contact us if you could use some guidance/advice.