Areas of Expertise

Medical Device

The Lumino team will provide critical advice and support for your device development process – from management of preclinical testing, to preparation of regulatory submissions, to serving as your interface with the FDA. Our deep understanding of the science and regulatory expectations help ensure that we develop the best strategies to accelerate timelines and reduce development program risk.

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Pharmaceutical

Lumino can support the development of new pharmaceuticals and their submission to regulatory agencies worldwide. When you work with Lumino, you leverage considerable experience in developing successful preclinical and clinical testing strategies, as well as other critical product assessments in support of New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs). q

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Ophthalmic

Lumino can take a lead role in guiding you through the product development process from research to release, or we can support specific phases of your product development and regulatory journey: product concept, preclinical testing, CMC, quality systems development, clinical trials design and execution, and regulatory strategies and submissions. Our considerable ophthalmic experience makes us uniquely qualified to lead ophthalmic development projects.

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Quality Systems Consulting

A QMS system is a regulatory requirement that FDA/global regulatory inspectors and ISO auditors consider critical. Lumino can support development, oversight, and compliance auditing of your ISO, GLP, GMP quality systems and procedures.

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Sterilization Validation/Microbiology Processes Consulting

Lumino has the expertise to perform sterilization validation studies using Ethylene Oxide, Gamma, or Steam as appropriate to support ANSI, AAMI and ISO 11135, 11137, and 17665 standards. In addition, we can review your microbiology processes to ensure regulatory compliance, including environmental monitoring and clean room evaluations; bioburden monitoring and trending programs; package shelf life evaluations; and on-site steam sterilizer validations.

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