We support a wide array of companies, both domestic and local, to efficiently and successfully bring their new products to markets worldwide.
Ora’s pre-clinical and clinical models, unique clinical methodologies and regulatory experience as well as expertise, have been refined and proven across thousands of projects both in the US and internationally. We bring together the world’s most extensive and experienced network of ophthalmic experts and R&D professionals to maximize the value of new product initiatives.
Ora Japan is the local regulatory and clinical operations center for Ora, the world’s leading ophthalmic development services provider. Ora Japan is located in downtown Osaka and Tokyo, within the heart of Japan’s biotech corridor.
Strategic Consulting & Indication Selection
Study and Clinical Program Design
KOL Advisory Board Meeting
Turnkey Clinical CRO Services: Phase I – IV
IDE/510K/PMA/PIND/Scientific Advice/End of Phase 2/Pre-NDA Meetings
Regulatory Submissions/Briefing Packages and regulatory authority interface (FDA, EMA and PMDA)
Medical Writing and Publication Support
Support for Marketing, Advertising, and Product Commercialization
Business Development & Creative Business Models
Product/Pipeline Analysis to Evaluate Assets for Ophthalmic Indications
Supporting Entrepreneurs, Biotech, Start-ups, and Pharma
Strategic Business and Development Planning
Due Diligence Support (Business and Technical)
Network of Investors and Pharmaceutical Partners
- Access to Deal Flow
- Strategic Partner for Ophthalmology Companies and Companies New to Ophthalmology
Ora Supports for Japan Business
- Japan Companies considering development pathways in the US/EU
- Companies external to Japan looking to develop in Japan
- Japanese Companies with products seeking partners outside Japan
- Companies looking for pharma partners in Japan
Clinical Models, Endpoints, and Scales
Ora is the leading pharmaceutical and device services expert in all indications of the eye, including the front and back of the eye. We have developed validated clinical models that are accepted as regulatory endpoints in allergic conjunctivitis (Ora-CAC® model), dry eye (CAE®) and inherited retinal diseases (Ora-VNC™ mobility course). We will collaborate with you to design the optimal study and the associated endpoints to accelerate your timelines and achieve the goal of your program.
Ora has partnered with many companies to develop novel anti-allergic products efficiently and reliably in Japan. It uses its Ora-CAC® model, as well as other models to our partner’s benefit. Ora uses its standard CAC® (e.g. anti-histamine) and modified CAC® (e.g. anti-inflammatory) to accelerate the development of innovative therapies with a broad range of mechanism of actions. Ora has partnered with the Kitasato Institute to bring the standard Ora-CAC® allergy models to Japan and integrating with the experimental operations at Kitasato Institute.
To learn more about Ora Japan‘s capabilities, fill out the form below to download our brochure.
Ora Japan K.K.
Hilton Plaza West Office Tower
18F, 2-2-2 Umeda, Kita-ku
Osaka, 530-0001, Japan
300 Brickstone Square
Andover, Massachusetts USA 01810
tel: +01 978 685 8900
fax: +01 978 689 0020
Ora Japan K.K. (Tokyo Office)
Asahi Seimei Otermachi Building
3rd Floor, 2-6-1
Tokyo, Japan 100-0004