At the end of a very long, very expensive five years of testing and following a rigorous, strict application process, Biodx has finally achieved EU registration* for their b bioactive™ (DECONT-X™) disinfectant technology.
“It’s been a daunting road but 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, scientist Dr Jan Reynhardt, CEO of GrnCAT Holdings, together with Dr Lucia Steenkamp, principle scientist at the CSIR and her team, who offered irreplaceable guidance throughout the research,” says Burt Rodrigues, proud 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 DST (Department of Science and Technology), IDC (Industrial Development Council) and the TIA (Technology Innovation Agency) who initially helped us get this project off the ground.”
What this means to Biodx
“Above all 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 in front of us. But it’s much more than just having the finance to throw at it. You need to keep the faith for the dark periods. It was a painstaking process of following the regulatory process, step by step, until you reach the top of that hill. Today it’s truly humbling that this ten year 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.
*Ctgb Registration Number 16226 N