Lumino can support the development of new pharmaceuticals and their submission to regulatory agencies worldwide. When you work with Lumino you can leverage considerable experience in developing successful pre-clinical and clinical testing strategies, as well as other critical product assessments in support of New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs).
Preclinical testing strategy development is an essential planning step in pharmaceutical drug development that ensures that the clinical program is adequately supported in a timely and efficient manner. Lumino advisors can build a regulatory acceptable testing strategy that will meet your project plan and timeline- every time.
Lumino advisors have decades of experience designing preclinical studies and programs across a multitude of indications and for various geographies. Our experts can oversee and monitor your studies for technical competence as well as GLP compliance and can manage any issues that might arise.
Lumino advisors can serve as a member of your project team ensuring that preclinical regulatory expectations and documentation are met and that the preclinical program adequately supports your drug development project.
A safety assessment evaluates the toxicity of individual chemicals, ingredients, and impurities or ingredients in a product or those identified following extractable leachable testing. Safety assessments created by Lumino Advsiors 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 product development.
At Lumino Advisors, we have prepared numerous Preclinical Regulatory documents including briefing documents, INDs, NDAs and MAAs. We participate regularly in interactions with FDA and other Health Authorities. Applying our experience as both a previous sponsor and consultant, we know how to present and defend the datasets to ensure your success.