About Regulatory Affairs

A deep understanding of the Regulatory environment is at the core of the Accelagen team. When developing a regulatory strategy, our focus is on creating the most effective pathway to approval, whether for new-to-market therapeutic goods or for obtaining ethics committee approval to commence your clinical trial. Our expert team is involved early to help you map the strategic pathway, considering the desired outcome and working back to clearly define the first steps we need to take together.  Our team ensures the right strategy is in place from the beginning, with a focus on aligning regulatory milestones with clinical trial objectives.

With over 50 successful marketing applications completed, 12 IND/IDE submissions and 350+ Device Approvals both locally and globally, together we can accelerate human health and wellbeing.

What we offer

Dossier Gap Analysis

Submission Management


Submission Publishing

Market Authorisation

Lifecycle Management

Safety & Pharmacovigilance

medical writing banner

In-House Resource Support


Lifecycle Management

researcher using microscope

Safety & Pharmacovigilance

Want to have a tangible impact on the future of human health together?