Lumino can take a lead role in guiding you through the product development process from research to release. Of we can support specific phases of your product development and regulatory journey – from product concept to pre-clinical testing; from CMC to quality systems development; and clinical trials design and execution to regulatory strategies and submission. Our considerable ophthalmic experience makes us uniquely qualified to lead ophthalmic development projects.
Program and testing strategy development is a key step for both ophthalmic medical device and pharmaceutical development projects to ensure that they are adequately designed and conducted in a timely and efficient manner. Lumino Advisors can build a regulatory acceptable testing strategy that covers your medical device or pharmaceutical clinical and preclinical programs (including Toxicology, Analytical, Formulation and Microbiology) and will meet your project plan and timeline- every time.
A properly designed preclinical program for ophthalmic products can save both time and money while adequately supporting the clinical program and eventual registration. Lumino Advisors have designed and overseen these unique preclinical programs for both medical devices, pharmaceutical products and combination products. In designing your program, the experts at Lumino consider the uniqueness of your product when selecting the appropriate species, critical non-traditional endpoints, study timing, and evaluation of the nonclinical results.
Appropriately designed clinical programs and studies can save both time and money while most importantly meeting regulatory scrutiny. Lumino advisors have decades of experience designing clinical studies for both ophthalmic medical devices and pharmaceutical products (multiple indications) for various geographies.
A safety assessment evaluates the toxicity of individual ingredients in an ophthalmic formulation or chemicals identified following extractable leachable testing. Safety assessments created by Lumino advisors take into account many parameters including the route and duration of exposure, indication, nature of material, and likelihood of exposure. Using data, literature, regulatory experiences and our strong scientific knowledge, Lumino advsiors can prepare in depth position papers on a variety of topics intended to support your ophthalmic device or product.
Lumino advisors have decades of experience monitoring studies for technical competence as well as GLP compliance. We can help can design, place, and oversee your studies and manage any issues that might arise.
Lumino advisors have decades of experience designing ophthalmic preclinical studies and programs across a multitude of indications and for various geographies. We can participate as a member of your project team ensuring that preclinical regulatory expectations and documentation are met and that the preclinical program adequately supports your medical device or drug development project.
At Lumino Advisors, we have prepared numerous clinical and preclinical regulatory documents including briefing documents, 510 (k) submissions, INDs, NDAs and other marketing applications. We participate regularly in interactions across divisions of FDA and other Health Authorities and applying our experience as both a previous sponsor and consultant, we know how to present and defend the datasets to ensure success.