Since its founding in 1999, AJW Technology Consultants has developed a client base of over 400 companies from around the globe, serving anywhere between 100-150 clients in a given year. We offer a wide range of services to the medical device, pharmaceutical, and biologics industries. The core business centered around Quality Management and Regulatory compliance activities for medical devices, with a focus on building mutually-beneficial client relationships and sustained growth primarily through word-of-mouth referrals. Since 2011, the company has increasingly concentrated on developing a more comprehensive offering for client companies. In sum, this has led to the founding of several new affiliate companies offering services ranging from clinical trials to the development of electronic quality management systems.
Today, we have offices in the US, Australia, New Zealand, India and the United Kingdom providing in-country representation and regulatory agency submissions. Additionally we have ‘Channel Partners’ providing similar services in Latin America and Central America. While quality and regulatory compliance are still a significant part of the business, extensive internal expertise is supplemented by a solid network of diverse subject matter experts, enabling our team to provide a full suite of development and commercialization services to clients. Our team provides alignment between the numerous strategic planning and operational activities required prior to, during, and following product launch. Our expertise supports the product life cycle and covers activities ranging from ‘Early Development’ (engineering, design, clinical testing, regulatory strategy, quality systems, due diligence) to ‘Late Stage Support’( contract manufacturing, marketing intelligence, reimbursement strategy, clinical studies, and distribution). AJW Technology Consultants is well positioned to offer end-to-end solutions for your product development efforts.
• Design Engineering / Pre-clinical services: CAD, 3d Modeling, design history file support, risk management, software development, human factors engineering, sterilization validation, biocompatibility evaluation, UDI, labeling design
• Clinical strategy and trial management: protocol development, statistical analysis, medical writing, clinical evaluation, human factors, trial monitoring, data management
• Regulatory strategy: FDA, Health Canada, CE Mark, TGA ARTG, global device registrations, post market surveillance, merger and acquisition due diligence, access to former US FDA staff
• Quality management: ISO systems registration, FDA Inspection preparation, internal and supplier audits, contract manufacturer selection
• Reimbursement strategy: coverage consensus planning, reimbursement code identification, outcomes data, payment
• Marketing and Distribution strategy: 40+ global distribution partners, market research, product sales , new product launch