Lumino… to brighten; to illuminate, give light to; to light up; to reveal or throw light on.
Serving as an extension of your team, Lumino will help you design, and, as needed, execute evidence-based, regulatory-accepted strategies to help increase product development success in medical device, pharmaceuticals, and ophthalmics.
Lumino can take a lead role or support specific phases of your product development and regulatory journey – from product concept to preclinical testing; from chemistry manufacturing controls to quality systems development; and from clinical trials design and execution to regulatory strategies and submission.
Lumino’s strategic affiliation with iuvo BioScience offers easy access to safety, microbiology, toxicology, and analytical chemistry testing services and experience. In addition, iuvo’s recent acquisition of Oculos provides access to a fully-integrated ophthalmic R&D organization. Our thoughtful and candid approach to getting it right is supported by years of clinical and regulatory experience that allows us to give light to, and help you overcome, the challenges and expectations of dealing with ever-changing regulations and expectations of global regulatory approval agencies.
True to its definition, Lumino Advisors is just that. A passionate advocate for your success – a guiding light that can help you navigate the product development pathway from research to release. Here’s how:
- Over 100 years of combined experience in medical device and pharmaceutical development, with specific knowledge of ophthalmic product development
- Beyond the core Lumino team, we have a strong network of consultants with the expertise and experience to address any unique challenges you may have
- Extreme flexibility to support every phase or any phase of your project – from proof of concept to regulatory submissions
- Considerable direct and successful experience working with regulatory authorities
- An extension of your team, treating your project as if it was our own where our only goal is meeting your goals
- A proven track record of success having executed numerous successful INDs, NDAs, and 510Ks
