Specialized Expertise in Ophthalmic Devices and Ophthalmic Pharmaceuticals
We specialize in providing comprehensive ophthalmic consulting services to support your ophthalmic device or ophthalmic pharmaceutical development initiatives. With our deep expertise in ophthalmology and a client-centric approach, we offer tailored consulting solutions to address the unique challenges and regulatory requirements of ophthalmic product development. Our team of experienced ophthalmic consultants is committed to helping you navigate the complexities of the industry and achieve your vision health goals.
Expert Ophthalmic Consulting: Driving Innovation and Compliance
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.
Customized Solutions for Your Ophthalmic Consulting Needs
Every ophthalmic project is unique. That’s why we offer customized consulting solutions tailored to your specific needs. Our team will work closely with you to understand your challenges, objectives, and timeline, and provide targeted consulting services to address them effectively. We leverage our expertise and industry knowledge to deliver practical solutions that drive innovation, compliance, and vision health.
Program Design for Medical Device and Pharmaceutical Product Development
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 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.
Lumino has decades of experience monitoring studies for technical competence as well as GLP compliance. We can help design, place, and oversee your studies and manage any issues that might arise.
Regulatory Strategy and Compliance
Navigating the complex regulatory landscape is a key aspect of ophthalmic development. Our expert ophthalmic consultants have in-depth knowledge of global regulations, including FDA, ISO, and CE requirements. We can assist you in developing effective regulatory strategies, preparing regulatory submissions, and ensuring compliance with the applicable standards. With our guidance, you can navigate the regulatory processes smoothly and efficiently, saving time and resources while meeting the necessary requirements.
Preclinical Program Strategy and Study Design
A properly designed preclinical program for ophthalmic products can save both time and money while adequately supporting the clinical program and eventual registration. Lumino has designed and overseen these unique preclinical programs for 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.
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.
Clinical Program and Study Design
Appropriately designed clinical programs and studies can save both time and money while most importantly meeting regulatory scrutiny. Lumino has decades of experience designing clinical studies for both ophthalmic medical devices and pharmaceutical products (multiple indications) for various geographies.
Quality Management Systems (QMS) Development
Establishing robust Quality Management Systems is essential for ensuring product quality and compliance with regulatory standards. Our ophthalmic consultants can help you develop and implement effective QMS tailored to your organization’s needs. From designing standard operating procedures to conducting internal audits and facilitating CAPA (Corrective and Preventive Actions) processes, we support you in achieving a culture of quality excellence and continuous improvement.
Toxicology Safety Assessments and Position Papers
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 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 can prepare in-depth position papers on a variety of topics intended to support your ophthalmic device or product.
Regulatory Document Preparation/Health Authority Interaction
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.
Risk Management and Analysis
Identifying and mitigating risks is crucial for ophthalmic development. Our consultants have extensive experience in conducting risk assessments, including hazard analysis, failure mode and effects analysis (FMEA), and risk management file preparation. We help you identify potential risks, assess their severity, and implement risk mitigation strategies, ensuring the safety and effectiveness of your ophthalmic products.
Why Choose iuvo’s Lumino Advisors for Ophthalmic Consulting?
As your partner for ophthalmic consulting, you benefit from our expertise, client-centric approach, and commitment to excellence. We have a proven track record of helping clients navigate the complexities of ophthalmic development and achieve regulatory compliance. Our focus on collaboration, integrity, and delivering actionable insights sets us apart as a trusted consulting partner in the ophthalmic industry.