Medical product development is a complex, expensive, risky venture. How does one get from early findings (i.e., efficacy in a preclinical model of a disease) to an approved product? More important these days, how do you get to the key milestones as rapidly and efficiently as possible?
Based upon his decades of successful product development experience, Gary D. Novack, Ph.D., president and founder of PharmaLogic Development, Inc., can help you develop a strategic plan for your product. Once planned, he and his team of experts can help you execute that plan. Working in manifold therapeutic areas with pharmaceuticals, biologics and devices, the firm’s particular expertise is in local therapy (ophthalmology and dermatology).
Dr. Novack states “The more I work in the development of new pharmaceuticals, the more I see that early development is a complex interaction of pharmaceutics (formulation), safety assessment (local and systemic), and clinical planning. Not only do we help plan and execute what needs to be done, but what needs to be done when.” Many of his experiences and unique perspectives in product development may be found in the over two dozen editorials he has written as a contributing editor to The Ocular Surface.
PharmaLogic is a consulting service to the pharmaceutical, biotechnical and medical device communities. From our base in Northern California, we provide a number of services to our worldwide client base. Our services include review of preclinical data, strategic planning for clinical development, preparation of the IND, and development of protocols. We assist clients in the writing of final medical reports, NDA summaries, and manuscripts for peer-review journals. We also prepare business plans for the biomedical community.