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.