Thinking Ahead To Help You Move Ahead
Whether your need is to lay out your preclinical testing strategy for a new drug or device, to bring existing programs into compliance with the EU Medical Device Regulations, or to supplement your team with experienced professionals, iuvo’s Lumino Advisors consulting team can help you get your new medical device or pharmaceutical products to market.
Lumino Advisors provides access to a strong, well-connected team of research, development, and regulatory experts with direct industry experience to deliver the highest level of strategic vision and development confidence.
Serving as an extension of your team, Lumino will help you design and, as needed, execute evidence-based, regulatory-accepted strategies to increase product development success.
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 affiliation with iuvo offers easy access to safety, microbiology, toxicology, and analytical chemistry testing services and experience. In addition, iuvo provides access to a fully-integrated ophthalmic R&D organization, from preclinical services to clinical research.
Meet Mary Richardson, PhD, DABT
- 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 knowledge and experience to address any unique challenges you may encounter
- Extreme flexibility to support 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 to help you meet your goals
- A proven track record of success, having executed numerous successful INDs, NDAs, and 510Ks
To contact our specialists or learn more about our services, please reach out to us, and we’d be happy to help you with your application.