New website

It is with great pride and joy that we announce the website for maartennas.com domain is ready for launch. Since the beginning of our company, we have supported 9 clients with 13 audits and …

FDA First Biosimilar Approval

We are very pleased to announce the approval of the first biosimilar by the FDA of Zarxio (filgrastim-sndz). Our company provided support in FDA pre-inspection preparations for about 2,5 …

Usefull links

New EU Clinical Trial Legislation

ICH-GCP E6

FDA Press Announcement First Approval Biosilmilar

Overview of FDA Regulations Clinical Development

The EU Pharmacovigilance System

FDA Presentation on Pharmacovigilance

Comparison of EU and USA PV regulations