For the latest updates on how we are managing changes due to COVID-19 please click here. Clinical Investigational Product Support Investigational Product Support Ora offers manufacturing guidance and oversight of cGMP clinical supplies and packaging, labeling, and distribution services to maintain the highest quality for your clinical trial materials. Investigational Product Packaging, Labeling, and Distribution We offer manufacturing support which adheres to Good Manufacturing Practices (cGMP), and can provide you with appropriately formulated clinical trial material packaged and ready for the clinic. Acceptable ophthalmic formulations can be manufactured from a client’s drug product, raw API, solid dosage form repurposed for the eye, or from an OUS-approved ophthalmic solutions to be manufactured in the US by cGMPs Our Investigational Product Support Services Conduct audits of your active pharmaceutical ingredient (API) manufacturer Assess available or historical CMC information Identify the most cost-effective and time-efficient Ora third-party drug product manufacturer and controls facilities Assist in the development of ophthalmic formulations Provide guidance on manufacturing standards, drug quality, controls, stability programs Compile and/or review CMC material for pre-Investigational New Drug (IND) meetings, INDs, New Drug Applications (NDAs), and Biologics License Application (BLAs) Train study personnel in compliant, on-site preparation of unusual test articles Labeling and Distribution for Clinical Trials When you use a third-party labeling vendor, the risk of delay increases. To give you more customized control of your study’s timelines, let Ora perform all labeling and distribution functions for your clinical trial. Overseeing Every Step of the Labeling and Distribution Process Step 1: Generate of randomization codes Step 2: Manage the Interactive Web Response System (IWRS) Step 3: Produce labels and create labeling control policies and procedures Step 4: Secure controlled and alarmed storage facilities for drug product Step 5: Distribute product to sites after training them on storage and dispensation Ora Headquarters 300 Brickstone Square Andover, Massachusetts 01810 United States of America Contact Us tel: (978) 685-8900 fax: (978) 689-0020 Stay in Touch Follow us on social media Copyright © 2020 Ora, Inc. All Rights Reserved. Privacy Policy Site Map Contact Us Ora, Inc websites use cookies. By continuing to browse the site you are agreeing to our use of cookies. For more details about cookies and their use, please see our Privacy Policy. CONTINUE