Quality and regulatory solutions for pharma.

We can support you with worldwide regulations and directives thanks to our team of carefully selected professionals with decades of combined experience in the pharmaceutical industry.

Our solutions

Thanks to our know-how of the manufacturing and distribution aspects of pharmaceutical products, we are perfectly qualified to offer you practical solutions.

Manufacturing & Importation Authorization

MIA License in an EU State

EU-CTD

Compilation of Regulatory Dossier

Manufacturing Site EU GMP Certification

EU Certification of Your 3rd Country Manufacturing Facility

EU Marketing Authorization

Approval of Your Dossier within the EU

EU Batch Testing & Release

Analysis according to dossier and certification by EU QP

Pharmacovigilance

Post Marketing Activities

Helping you identify your business needs

We can help you remain up-to-date on EU regulations at all times with flexible and tailor-build solutions designed on your business needs.