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.
Insights from our experts & news from the industry
EU Product Registration Ep.12
Laura OgnibeneGiugno 24, 2024
GDP Audits
Laura OgnibeneGiugno 17, 2024