Regulatory CMC Contractor for an Ophthalmic Drug Company

Client background

This client is developing and commercializing innovative ophthalmic products for the treatment of serious eye disorders.  They have two approved products and multiple programs in clinical trials.


The client’s Regulatory CMC person recently resigned, so they were seeking a Regulatory CMC Consultant/Contractor who could prepare and review CMC sections of INDs, IMPDs, CTAs, and also handle post-approval changes.  They wanted somebody who could work full time until the permanent role was backfilled.


Dennis Partners searched for Regulatory CMC contractors and consultants with sterile injectable and drug/device combination product experience. We were able to find six good contractors who met the client’s qualifications within a few days of launching the search.


The client conducted video interviews with the top two contractors and made a decision within two days. Once they picked their top choice, Dennis Partners assisted with reference checks, background checks, timesheets and payroll processing. The contractor started working for the client within two weeks of starting the search!