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. This has given us knowledge of the requirements of each market and we have amassed extensive experience on different markets. 

Our Quality System is designed to meet FDA 820 and ISO 13485:2016 requirements and we are certified in the latter under the MDSAP program. Our GMP quality system is regularly audited by worldwide agencies and our quality and regulatory staff sit on several trade panels to represent industry interests. 

We can handle registrations in Europe (CE marking) and the USA (FDA), as well as provide support in registrations in other countries. 

Our Market Surveillance team manages activities in complaints, field actions and vigilance systems. 

Clinical studies

Broad expertise in Europe, the USA and China, among others

Extensive experience in clinical studies, including: 

  • Alpha sites 
  • Clinical studies for CE marking 
  • Clinical studies for FDA 510(k) 
  • Clinical studies for FDA PMA 

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

  • FDA pre-subs and submissions 
  • Selection and qualification of clinical sites 
  • Writing of study protocols and associated documents 
  • Contracts & SOWs with clinical sites 
  • CRFs (case report forms) 
  • Prospective sample collection, informed consent and leftover sample management 
  • Site initiation, monitoring and closeout 
  • Data management and analysis 
  • Writing of reports