Cut costs, save time and secure your business with AI specialized in the Belgian context.
MA, pharmacovigilance, clinical trials, medical devices — FAMHP regulations change constantly and sanctions are heavy.
Regulatory compliance costs €50,000-200,000/year for a Belgian biotech. Specialized consultants charge €250-400/h.
An MA application takes 12-24 months. Every file error adds 3-6 months. Time-to-market is critical.
PharmaPro masters FAMHP, MA procedures, pharmacovigilance, clinical trials and NIHDI reimbursement.
Try for freeAudit your FAMHP, GDP, GMP, pharmacovigilance and clinical trial compliance. Report with prioritized action plan.
Try for freeGenerate eCTD, pharmacovigilance reports, PSURs, clinical trial protocols and NIHDI reimbursement files.
Try for freeRegulatory costs/year
MA file preparation time
FAMHP rejection rate
Pharmacovigilance compliance
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Dr. Janssens, CEO of a 45-person biotech in Leuven
His biotech was spending €150,000/year on regulatory consultants and his first MA file had been rejected for documentary deficiencies.
PharmaPro guided the file correction, the audit identified 8 non-compliances, the generator structured the complete eCTD file.
Join the Belgian users who trust KonsultIA.