Worldwide expertise

Regulatory affairs & clinical studies

Extensive global experience in regulatory affairs and clinical studies. 
Our dedicated teams apply their experience and accumulated knowledge to make your assays a reality on the market. 

Make your product available on your market of interest

We can help you with the registration process and clinical studies needed on every market.

Regulatory Affairs

Worldwide expertise in registration

For Werfen, having a global presence is key. We can handle registrations in Europe (CE marking) and the USA (FDA), as well as providing support in international registrations worldwide. Across the years, this experience has given us extensive knowledge of the requirements in each market. 

Our GMP-compliant Quality System is designed to meet FDA 21 CFR 820 and ISO 13485 requirements and we are certified both under ISO as well as under the MDSAP program. Our QMS is regularly audited by notified and certification bodies, and has been successfully inspected by worldwide agencies, including FDA. Furthermore, our quality and regulatory expert staff sits on several trade panels of relevant associations to represent industry interests. 

CLINICAL STUDIES

Broad expertise in Europe and the USA

Extensive experience in clinical studies, including:  

  • Clinical studies for CE marking IVDR
  • Clinical studies for FDA 510(k) & PMA
  • Method comparisons and performance evaluations 

We can design the most suitable clinical study plan for your products and execute it:  

  • Clinical studies managers participating in the cross functional teams during all reagent development allows great knowledge of the product
  • All studies phases under GCPs (Good Clinical Practices)
  • Selection and qualification of worldwide clinical studies sites 
  • Statistical Analysis Plan
  • Writing of study protocols and associated documents and reports under GDP
  • Contracts & SOWs negotiation with clinical sites 
  • IRB/EC submissions
  • Patient recruitment, sample collection, informed consent and leftover sample management 
  • All data captured into electronic CRFs (Case Report Forms) 
  • Site initiation, on site and remote monitoring and closeout visits
  • Data management and data analysis 
  • FDA pre-subs and submissions clinical accountability