Advancing Retinal and Ophthalmic Innovation from Bench to Clinic
Nayana Medical LLC is an independent, ophthalmology- and retina-focused contract research organization dedicated to advancing retinal therapeutics and medical devices from the bench to the clinic. We provide integrated preclinical, translational, GLP-compliant, CMC, and clinical consulting services, including in vitro and in vivo research support, to biotechnology and medical device companies. Our engagement model is execution-focused and advisory, supporting high-quality data generation, regulatory readiness, and development continuity within a collaborative sponsor framework.
Our Services
Nayana Medical provides comprehensive preclinical research services to support early- and mid-stage development of retinal therapeutics and ophthalmic medical devices. Our capabilities span in vitro and in vivo studies conducted under both non-GLP and GLP-compliant frameworks, enabling efficient hypothesis testing, translational validation, and regulatory-ready data generation.
We support assay development, mechanism-of-action studies, dose ranging, proof-of-concept efficacy, and safety assessments in relevant ocular models, with study designs tailored to program stage and regulatory objectives. GLP-compliant studies are executed with appropriate quality systems, documentation, and oversight to support IND/IDE-enabling submissions, while non-GLP studies are structured for speed, flexibility, and decision-making.
Our preclinical programs are designed to integrate seamlessly with downstream CMC, toxicology, and clinical strategies, ensuring scientific rigor, traceability, and continuity from early discovery through regulatory submission.
Nayana Medical provides strategic and execution-focused CMC support to advance ophthalmic therapeutics and medical devices toward regulatory readiness. Our services are designed to bridge early development through IND- or IDE-enabling milestones by aligning analytical rigor, manufacturing strategy, and regulatory expectations.
We support analytical assay development, optimization, and qualification, including potency, identity, purity, safety, and quantitative assays to support preclinical studies, stability programs, and clinical manufacturing. Our team works closely with sponsors and external CDMOs to ensure assays are fit-for-purpose, appropriately qualified for their intended use, and documented to support regulatory submissions.
CMC services also include manufacturing strategy advisory, process development oversight, comparability planning, stability study design, and coordination of GLP and GMP-adjacent activities. Through an integrated and pragmatic approach, we help ensure data integrity, regulatory alignment, and continuity across the product lifecycle.
Nayana Medical provides clinical development and regulatory consulting grounded in direct retinal surgical and clinical trial experience. Our clinical consulting services are led by a board-certified retinal surgeon with over a decade of experience in the management of retinal disease and the design and execution of ophthalmic clinical research.
We support clinical strategy development, protocol design, endpoint selection, feasibility assessments, and investigator engagement for retinal therapeutics and medical devices. Our approach emphasizes practical trial design, patient safety, and alignment with real-world clinical practice, with a focus on early-phase and first-in-human studies through later-stage clinical development.
By integrating clinical insight with preclinical, regulatory, and CMC considerations, we help sponsors design efficient, credible development programs that are operationally feasible, clinically relevant, and positioned for regulatory and commercial success.
About
our company
Nayana Medical LLC is an independent, ophthalmology- and retina-focused contract research organization dedicated to advancing retinal therapeutics and medical devices from early development through clinical translation. We partner with biotechnology and medical device companies to deliver rigorous, stage-appropriate scientific and regulatory support across the development lifecycle.
Our capabilities span preclinical research, including in vitro and in vivo studies conducted under non-GLP and GLP-compliant frameworks, as well as CMC and clinical development consulting. We combine deep retinal disease expertise with practical execution to generate high-quality data, support regulatory readiness, and enable informed development decisions.
Nayana Medical operates with a collaborative, execution-focused model, integrating seamlessly with sponsor teams and external partners. Our mission is to provide disciplined, ophthalmology-specific expertise that accelerates development timelines while maintaining scientific rigor and regulatory alignment.
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Have a program you’d like to discuss, or need support across preclinical, CMC, or clinical development? We welcome confidential inquiries and will respond promptly.
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