Market Introduction

Continuous support during your market introduction

In an ever-changing landscape, your company needs continuous support to reach its corporate strategic goal and investors’ expectations.

In close collaboration with your team, we will develop a plan to meet the regulatory requirements, applicable guidelines, and authorized representation that you need, while respecting budget and timelines.

We specialise in IDE Trials, FIM trials, Pre CE trials & research, FDA trials, and regulatory consultancy.

Support in every phase of your clinical research

IDE trial, FIM trial, Pre CE trial & research,
FDA trial, and regulatory consultancy.

The foundation of a successful clinical program is key in a solid regulatory strategy. As a full-service CRO, we support you in every phase during this clinical research: protocol development, site selection, submission processes, safety and Adverse Event management (DSMB, CEC), onsite- and remote monitoring, statistical analysis, reporting, and medical writing, whether you are preparing for a FIM, an IDE, or pre CE-mark trial.

Quote by T. Duncan

“Good, better, best… Never let it rest, untill your good gets better and your better gets best.”

Testing & Validation Testing & Validation Testing & Validation Testing & Validation Testing & Validation Testing & Validation Testing & Validation