Chemistry, Manufacturing, and Control (CMC)

Ora’s CMC professionals offer distinct advantages within the ophthalmic development process to help your company quickly and efficiently advance your drug candidates to the next stage.

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PMP-certified project management
and ophthalmic product expertise for on-time/on-budget delivery of clinical supplies and test articles
Ophthalmic formulation screening
in close collaboration with Ora pharmacology/toxicology and clinical regulatory teams
Integrated, world-class product development
strategy with early engagement of Ora’s top clinical and preclinical teams
Experienced CMC regulatory writing and consulting
(pre-IND, IND, EOP2, CTD, NDA)

We have managed the supplies for numerous clinical trials, and we can adeptly handle complex designs and international studies.

In order to provide a one-stop turnkey solution to clients, Ora has built long-standing relationships with a strategic network of contract manufacturing organizations, suppliers, and consultants. Projects are assessed and defined in detail and then proactively managed to completion using established processes and best-industry practices.

Typical Ora CMC program management activities include the following:

Project management
  • Project assessment/ risk evaluation/ kick-off meeting
  • RFP preparation and collection of proposals from CMOs
  • Vendor management contract/ invoice review
  • Detailed project plan and progress monitoring
  • Weekly teleconferences/ minutes
CMC technical program management
  • Technical consulting,document review/ approval
  • CMO Deviation and CAPAs review/ approval
  • Pharmaceutical development report
Regulatory affairs management
  • Regulatory records file
  • IND CMC section
Clinical labeling/ packaging/ distribution
  • Clinical supply design and protocol with label texts and packaging specifications
  • Clinical supply materials procurement (boxes, sleeves, seals)
  • Randomization list design/ handling
  • Label proof and master packaging record review/ approval Unmasking envelopes (if needed)
  • Clinical supply distribution
  • Drug destruction
CMC Quality Assurance
  • Master batch and packaging record review/ approval
  • Clinical supply protocol review/ approval
  • Clinical stability protocol
  • Release certificates
  • IND review/ approval