Worldwide expertise

Regulatory Affairs & Clinical Studies

Global and extensive experience in Regulatory Affairs and Clinical Studies.
Our dedicated teams apply the experience and accumulated knowledge to make your assays a reality in the market.

Make your product available in the market of your interest

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

Regulatory Affairs

Worldwide expertise in registration

Global presence is a key issue for Biokit. This has made us know the requirements of each market and we have achieved a wide experience in different markets.

We can make the registrations in Europe (CE mark) and in the USA (FDA), as well as give support in the registries to other countries.

Different agencies (Notified Bodies, FDA, WHO, ANVISA and NMPA among others) have certified our products and processes.

Our Market Surveillance team carries out the activities of Complaints, Field actions and Vigilance system.

Clinical studies

Broad expertise in Europe, USA and China, among others

Extensive experience in Clinical Studies, including:

  • Alpha sites
  • Clinical Studies for CE mark
  • Clinical Studies for 510 (k) FDA
  • Clinical Studies for PMA FDA

We can design the Clinical Study Plan more suitable for your products:

  • FDA pre-sub and submissions
  • Clinical sites selection and qualification
  • Study protocols and associated documents writing
  • Contracts & SOWs  with clinical sites
  • CRF (Case Report Form)
  • Prospective collections, informed consent and leftover samples
  • Site initiation, monitoring and close out
  • Data management and analysis
  • Report writing