About iV PASS

We are a French company with offices located in Anglet (France) and Silverdale (NSW, Australia). We specialize in accompanying our clients in their regulatory strategy. We provide regulatory writing, audit and training services for CE MARKING of IVDMDs manufactured on an industrial scale and regulatory compliance of IVDMDs manufactured and used on a non-industrial scale by health institutions.


About our services

assisting-clients-in-regulatory-strategy

DEFINITION OF THE COMPREHENSIVE STRATEGY

GAP ANALYSIS BETWEEN EXISTING AND REQUIRED DOCUMENTATION

documentation-analysis-and-optimization
TECHNICAL AND QMS DOCUMENTATION WRITING
regulatory-training-for-customers

TRAINING

Meet our expert

Nadine AUTRAN, PhD

Chief Executive Officer & Senior Regulatory Consultant

With more than 25 years of experience in the life science field, I spent the last 10 years involving myself in regulatory compliance projects, in the human and animal health industry.

I evolved from R&D roles in the biologicals sector, to positions in RA/QA and Production in the IVD sector. I bring a wide overview ranging from the feasibility studies to the registration dossier.

Prior to working in the health industry, I dedicated myself in research and education from which I nurture my fondness for innovation, knowledge improvement and communication.

Outgoing, logical and decisive, I have a strategic approach to gaining the very best from every effort.

The best of collaboration for you

To meet our clients’ regulatory constraints, we insure a comprehensive approach in collaborating with different external entities each expert in its own specialized field. 


AUDIT

DATA MANAGEMENT

BIOSTATISTICS

ANALYTICAL & CLINICAL PERFORMANCE STUDIES MANAGEMENT

iv-pass-regulatory-consulting-logo