Clinical Program Management
Ora’s device operations group has excelled at all levels of clinical research. The team has led all phases of clinical research to support regulatory filings.
10+ in recent years
20+ in recent years
|IDE PACKAGE SUPPORT||10 in recent years|
|HUD APPLICATIONS||3 in recent years|
|EFS PATHWAYS||2 in recent years|
|PRE-SUBMISSIONS||30+ in recent years|
Over the past 40+ years, Ora has played a significant role in the development of marketed ophthalmic products.
Our experience covers consulting projects and clinical trials in ophthalmology, and extends beyond therapeutics to our industry-leading experience in ophthalmic medical devices. In the last three years alone, we’ve had more than 30 FDA pre-submissions and more than 10 products submitted for marketing applications. Ora’s regulatory experts have long-standing, established relationships with the CDRH branch of the FDA and other international regulatory agencies. Ora is proficient in ophthalmic medical device regulatory consulting, including presubmission to FDA and conducting clinical trials to support marketing applications.