Be a recognized, high quality, efficient and affordable service provider.
To provide our clients with comprehensive, highly specialized, high-quality and fast consulting services and realize their projects in the field of regulatory compliance and registration of medicinal products, pharmacovigilance, pricing and reimbursement, and medical devices.
Our clients are small enterprises as well as large international pharma corporations.
Our network of experts and consulting partners with wide experience from the pharmaceutical industry and from the competent authorities enables us to deliver excellent expertise across a broad range of areas. Our partners are localized across the Europe. We provide our services within the EU.
The company is managed by:
MUDr. Klara Michalkova – Managing director, EU QPPV
Klara is an expert in medical writing and pharmacovigilance. She is the former Managing Director of Sanofi Pasteur. She has excellent and unique experience in medical science and market access, especially with vaccines. She is also experienced EU QPPV.
Ing. Alena Pychova – RA/QA director
Alena is an expert in regulatory affairs and manufacture. She worked for the Czech competent authority (State Institute for Drug Control) as pharmaceutical assessor. She provided assessment for quality part of dossiers within MAA and CTA for biotech products, biosimilars, vaccines and ATMP. She is the former member of Biological Working Party at EMA.