Since its founding in 1999, by Dr. Art Ward, AJW Technology Consultants has developed a client base of nearly 500 companies from around the globe, offering a wide range of services to the medical device, pharmaceutical and biologics industries. The core business centered on Quality and Regulatory compliance activities for medical devices, and a focus on building mutually-beneficial client relationships generated continuous growth over the years from word-of-mouth referrals.
Today, we have offices in the US, Australia, New Zealand, Germany, India and the United Kingdom providing in-country representation and regulatory agency submissions for medical products. Additionally, we have ‘Channel Partners’ providing similar services in Latin America and Asia. 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 expertise supports the product life cycle and covers activities ranging from ‘Early Development’ (product concept and pitch development, investor relations, design engineering, clinical testing, regulatory strategy, quality systems, due diligence) to ‘Late Stage Support’ (contract manufacturing, marketing intelligence, reimbursement strategy, clinical studies, and distribution). Our organization is well positioned to offer end-to-end solutions for your product development and marketing initiatives.
To address persistent demand for our original core services, we also maintain a full-time presence of consultant experts at our home office in the greater Tampa Bay area. With decades of collective experience, this group specializes in efficiently executing short- and long-term onsite projects to address regulatory and quality compliance needs for local medical device manufacturers.
Company’s Keywords:
fda registration, european technical files, iso 13485 quality management systems, internal & supplier audits, regulatory strategy, 510 submissions, ce marking, eu authorized representative, contract design, iso 14971 risk management, custom quality system development, clinical studies, usability testing, mock fda inspection, design controls, qms training, design file remediation, audit preparation
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