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