Ora Japan
 
Ora is the world's leading independent, full-service ophthalmic clinical research and product development firm with offices in the United States and Japan. Over the past 30 years, we helped our clients earn 39 regulatory approvals.

We support a wide array of organizations, from start-ups to global pharmaceutical and device companies, to efficiently and successfully bring their new products from concept to market.

Ora's pre-clinical and clinical models, unique methodologies and regulatory strategies 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, K.K. is the local regulatory and clinical operations center for Ora, the world's leading ophthalmic CRO. Ora Japan is located in downtown Osaka, within the heart of Japan’s biotech corridor.

Global R&D

  • Strategic Consulting & Indication Selection
  • Study and Clinical Program Design
  • KOL Advisory Board Meeting
  • Formulation/CMC Management
  • Pharmacology/Toxicology
  • Preclinical Models
  • Turnkey Clinical CRO Services: Phase I – IV
  • Data Management
  • Biostatistics
  • IDE/510K/PMA/PIND/Scientific Advice/End of Phase 2/Pre-NDA Meetings
  • Regulatory Submissions/Briefing Packages and FDA Interface
  • Medical Writing and Publication Support
  • Marketing, Advertising, and Product Commercialization

Business Development & Creative Business Models

  • Product/Pipeline Analysis to Evaluate Assets for Re-Purposing into Ophthalmic Indications
  • New Product Incubator
  • Strategic Business Planning
  • Due Diligence
  • Network of Investors and Pharmaceutical Partners

For more information, please visit www.oraclinical.com

Allergy Research

Ora has brought its Ora-CAC Model System™, as well as its entire family of Allergy Models to Japan, in order to develop novel anti-allergic products efficiently and reliably. The Ora Japan team looks forward to accelerating the development of innovative therapies for Japanese patients.

To learn more about Ora Japan's Allergy capabilities, download our brochure.

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Ora Japan K.K.
Hilton Plaza West Office Tower
18F, 2-2-2 Umeda, Kita-ku
Osaka, 530-0001, Japan
Tel: +(81)-6-6133-4393
Fax: +(81)-6-6133-4394

Ora
300 Brickstone Square
Andover, Massachusetts 01810
tel: +01 978 685 8900
fax: +01 978 689 0020