Delivering Innovative Solutions
Who We Are
624Advisors, LLC provides strategic and functional advisory and services, including ongoing Product Lifecycle Management compliance and medical writing across the medical device, drug-device combination, and IVD/CDx/biomarker diagnostics, Biomarkers as a Drug Development Tool, LDTs, CLIA, across therapeutic sectors, reducing costs and increasing speed-to-market through organized milestone-based roadmaps thus building certainty into the commercial probability and viability process. We help to build the strategic regulatory and clinical trial roadmap and the cost-effective use of 624Advisors Subject Matter Experts needed to support success in achieving the true Value Proposition for your company. We collaborate to build the Stakeholder Risk-Based Value Proposition Product Development Roadmap. 624Advisor, LLC works with its product development partners to first understand the product and goals of our partners and then work seamlessly to map and execute a strategic development plan. This leads to a cost-efficient Strategic Product Development and Regulatory Program in sync with the business goals of the client.
The 624Advisors principals and alliance partners are highly respected subject matter experts with extensive experience in regulatory strategies, product development, medical writing, clinical program design and compliance management, process development, clinical trial site and data management, and SaMD development and regulatory considerations. 624Advisors, LLC applies the knowledge and experience of its principals to provide strategic and tactical counsel and functional support.
624Advisors has also developed a network of best-in-class cross-functional drug and biotech alliances and AI-driven business management solutions. These relationships provide seamless cross-functional support for addressing complex regulatory requirements and building cost-reducing tools for data management, quality requirements, patient-centric care, and manufacturing scale.
Leadership
Dr Alan Touch – Founding Managing Principal and Principal Strategist 624Advisors, LLC
Thirty-five+ years of global, large corporate, and entrepreneurial emerging growth operating and hands-on senior management and consulting experience. He is the developer of the Stakeholder Risk-Based Product Development and Regulatory Value Proposition Roadmap. He has been a researcher, lecturer, writer, clinician, global regulatory and clinical trial strategist, and scientific and operational C-level executive. He has been a member of the Boards of Directors. This includes key strategic and operational input into the development, regulatory strategy, clinical trial design, and manufacturing scale-up of processes for product development, formulation development, for products including IVD and biosensor diagnostics, generic ophthalmic anti-inflammatory, anti-allergic, and dry eye pharmaceutical products, wound care, medical devices, and diagnostics. He has developed a novel approach to creating and implementing 21st Century Cures Act Clinical Quality Management Planning, SaMD for the US and EU, classification, and biomarker regulations.
Developed biomarker sample collection and ROC verification and validation clinical trial models and IVD development, preclinical performance verification and clinical validation clinical studies and standards for reimbursement and CLIA classification. Subject Matter Expert and Pioneer in Ocular Surface Disease and Subject Matter Expert in Medical Device and Diagnostics development, performance studies, clinical models compliant with US and EU regulatory requirements and product CLIA strategies. He was the Principal Strategist for INC Research (Syneos) leading the original growth and development of the Medical Device, Diagnostics, and Ophthalmology Business Unit. Currently, Founding Principal Strategist Advisor and hands-on SME serving large multinationals and early-stage growth companies at the intersection of regulatory, clinical, compliance, and business for global program management and technical support through 624Advisors, LLC.
He leads tactical management of the regulatory and clinical trial processes from concept to commercialization. He has led CDMO manufacturing pilot plant, full scale-up and oversight, QMS, GLP/GCP, and SOP development, quality assurance, and compliance for medical devices, diagnostics, and pharma. In addition to providing leadership for the regulatory roadmap, study design and protocol development for medical devices, diagnostics, and ophthalmology. He has led the development of Technical Documentation Files for submissions for CE mark applications and multi-country study start-ups, Dr. Touch has led the strategy and execution of IDE/PMA and 510(k) FDA submissions including de novo and other novel submissions such as NDA/PMA combinations, pre-submission meetings and the development of the product and corporate Value Proposition realization. He has overseen, managed and interacted in a matrix collaborative team management model on a wide cross-section of regulatory strategies, domestic and global studies of devices and diagnostics across multiple therapeutic areas. This includes biomarker and diagnostic verification, validation, pilot and pivotal studies protocol design and clinical trials for CDx. Dr. Touch has recently collaborated for complex drug-device combination regulatory and clinical, SaMD, medical device and diagnostic compliance, development and discovery, regulatory strategies, medical writing, and post-approval CLIA management.
We Are Here to Help
We pride ourselves on delivering tailored solutions that empower our clients to achieve their goals and drive innovation in their industries. Contact us to discuss regulatory roadmap consulting needs.