Regulatory Consulting Support for Biocides / Antimicrobials
Biocidal/antimicrobial products are subject to product registration requirements under the EPA’s Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the EU’s Biocidal Products Regulation (EU) No 528/2012 in the USA and EU, respectively. Based on product application, in the U.S. the Food & Drug Administration (FDA) may have jurisdiction over certain antimicrobial products. CSI has an established reputation in supporting registration of a diverse range of products including disinfectants, sterilizers, preservatives, and unique antimicrobial applications. We regularly assist clients requiring support to introduce their products in both the U.S. and European markets by developing cost-effective strategies.
In addition to our focus on the above US and EU regulations, we represent multiple clients with US State registration management and in meeting EU Member State requirements. We also support the needs of clients in meeting the registration requirements of the global marketplace, and have successfully assisted firms with registrations in Canada, Latin America, Asia (China/Taiwan), Australasia and other geographical markets.
The regulatory arenas and the regulated industries we serve continue to change. As a company, CSI’s strength has come not only from being able to adapt to industry trends, but by anticipating and applying new regulatory and scientific strategies to add value to client product development and registration pathways. Keeping pace in our consultancy has required us to stay current on regulatory drivers and scientific approaches to deliver our best for each individual client and project. We extend this dedication to you.
If you would like further information about CSI’s services in the Biocides sector, please Contact Us.