At the end of a very long, very expensive five years of testing and following a rigorous application process, Biodx has finally achieved EU registration for its b bioactive disinfectant technology.
“It’s been a daunting road and one where the end was only possible with the help of a dedicated team whose assistance made this dream a reality. Dr Mark Kelly, Biodx’s chief scientist – who has been with me every step of the way – and scientist Dr Jan Reynhardt, CEO of GrnCAT Holdings, together with Dr Lucia Steenkamp, principal scientist at the CSIR and her team, offered irreplaceable guidance throughout the research,” says Burt Rodrigues, CEO of Biodx.
“We’re also indebted to The Netherlands Organisation (TNO), who carried out the vital test work needed to meet the extremely strict levels of acceptance for this registration, together with Triskelion (Netherlands), who painstakingly prepared the necessary dossiers and followed through with the regulators.
“We also can’t forget the Department of Science and Technology, Industrial Development Council and the Technology Innovation Agency, who initially helped us get this project off the ground.”
What does this mean to Biodx?
“This now gives us access to the European industrial biotech markets (only registered products may be sold in the EU) which, with our product being proven and accredited in the EU against SARS-CoV-2, sees us poised for a successful entry, showing that South Africa can hold its own in this field.
“We started this journey in 2016, knowing there was a steep climb ahead. But it’s much more than just having the finance to throw at it. You need to keep the faith during the dark periods. It was a painstaking process of following the regulatory process, step by step, until we reached the top of that hill.
“It’s truly humbling that this registration conclusion is finally here, opening doors we only dreamed of. This is our first step in trading in the European market and hopefully the first registered dossier of many to come.”