AXIM Biotechnologies, Inc. has announced the engagement of 624 Advisors, owned and managed by Dr. Alan J. Touch, as Chief Medical & Regulatory Affairs Advisor. Dr. Touch is recognized as a preeminent expert in in vitro diagnostics (IVD) and companion diagnostics (CDx) with extensive global regulatory experience spanning more than three decades across diagnostics, medical devices, pharmaceuticals, and digital health.
The strategic appointment comes at a pivotal stage in AXIM's development as the company prepares for upcoming FDA 510(k) submissions, international regulatory expansion, and the establishment of robust quality and manufacturing infrastructure. Dr. Touch brings inventor-level knowledge of AXIM's technology, having been the original co-inventor of the first ocular diagnostic technologies acquired by the company. His background includes serving as Principal Strategist for Ophthalmology, Medical Devices and Diagnostics at INC Research (Syneos Health) and heading Clinical Affairs at Bausch & Lomb.
Catalina Valencia, President and CEO of AXIM Biotechnologies, emphasized the significance of this engagement for the company's regulatory and clinical capabilities. "Dr. Touch uniquely combines inventor-level knowledge of our technology with significant senior level experience in FDA regulation, ISO quality systems, clinical development, and manufacturing readiness," Valencia stated. "His involvement strengthens our regulatory strategy, quality foundation, and clinical execution, while positioning AXIM for efficient global expansion and long-term operational scale."
Dr. Touch's expertise specifically aligns with AXIM's current efforts in several critical areas. He possesses deep understanding of lactoferrin and immunoassay diagnostics, extensive experience across FDA, EU MDR/IVDR, and global regulatory frameworks, and proven leadership in regulatory affairs, quality systems, clinical development, and manufacturing scale-up. This engagement is expected to reduce AXIM's reliance on external consultants while accelerating readiness for commercialization and global growth.
For business and technology leaders monitoring the diagnostics and biotechnology sectors, this development signals AXIM's commitment to building what Dr. Touch described as "a strong foundation for market-sensitive and aware regulatory excellence and clinical credibility" for its products. The company's TearScan® platform, which enables clinicians to quantify tear biomarkers with laboratory-grade accuracy in office settings, represents a significant advancement in point-of-care diagnostics for ocular and systemic health. More information about AXIM's technology can be found at https://www.aximbiotech.com.
The engagement of a regulatory specialist of Dr. Touch's caliber reflects broader industry trends where regulatory strategy has become increasingly critical for successful product commercialization, particularly in highly regulated medical fields. As regulatory requirements continue to evolve globally, particularly with the implementation of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), companies with strong regulatory leadership are better positioned to navigate complex approval processes and achieve market access.
Dr. Touch expressed his commitment to advancing the technology he originally helped develop, stating, "I look forward to supporting an excellent and cohesive scientific, marketing and operational team as they advance key submissions, strengthen quality systems, and prepare for long-term manufacturing and commercial success." This appointment represents a strategic investment in regulatory expertise that could potentially accelerate AXIM's path to market while strengthening the company's position in the competitive diagnostics landscape.
