Investigational Product Packaging, Labeling, and Distribution

We offer manufacturing support of current Good Manufacturing Practices (cGMP) quality, and can provide you with appropriately formulated clinical trial material packaged and ready for the clinic.

How Ora’s CMC team can help:

  • 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 the ophthalmic formulation
  • 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

Acceptable ophthalmic formulations can be manufactured from:

  • A client’s drug product
  • Raw API
  • Solid dosage form to repurpose for eye
  • OUS-approved ophthalmic solutions to be manufactured in US by cGMPs

Clinical trial labeling:

Tight control of your study’s timeline should be in your hands. To give you more control, Ora can perform all labeling and distribution functions for your clinical trial. By keeping this function in-house, directed by your needs and implemented by Ora’s clinical team, and not a third party labeling outsourcer, the risk of a delay is minimized.

Ora closely oversees every step of the labeling and distribution process:

  • Generation of randomization codes
  • Management of the Interactive Web Response System (IWRS)
  • Label Production – as well as all policies and procedures to control labeling
  • Controlled and alarmed storage facilities for drug product
  • Product distribution to sites after training them on storage and dispensation

Read More About our Quality Compliance Services

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