cGMP Facility & Pilot Plant

Advance your Pharmaceutical Program with the CMC Laboratory

The chemists at CMC Pharma have tested hundreds of pharmaceutical drug products and are experts in method development, validation, and execution. CMC Pharma executes both routine and custom-designed ICH stability studies including long-term storage, accelerated and forced degradation conditions, compatibility and in-use studies, and container closure studies. We also develop and execute analytical methods which include testing APIs, drug products, and excipients using LC-Mass Spec, U/HPLC, Karl Fisher, osmolarity, dissolution, and more. Plus, we have the expertise and necessary equipment in the CMC laboratory to prepare prototypes of solid oral, injectables, and controlled release, long-acting dosage forms. 

 

With the help of CMC Pharma, expect more timely results for your pharmaceutical product development.

Located in Solon, OH, our state-of-the-art cGMP facility gives the team at CMC Pharma the tools and flexibility to help advance your pharmaceutical program. We are able to offer a full range of routine and custom lab services to help you get the timely, accurate results you need.

cGMP Compliant Laboratory

With a quality management system in place, we are able to provide cGMP lab services, allowing the data we generate to better suit your needs for the ultimate goal of product approval. To support product development, we provide cGMP lab services including release testing, method validation, stability studies, in-use, and compatibility testing.

CMC Pharma cGMP Lab
Mixing Device - CMC Lab Equipment
CMC Lab Equipment

Equipment

  • UHPLC
  • ICH Stability Chambers
  • UV/Vis Spectrophotometer
  • Karl Fisher Titrator
  • Osmometer
  • Analytical Balances
  • Tachometer

 

  • Condensate Recirculator
  • Environmental Chamber
  • Ultra Low Freezer
  • UV Sterilizer
  • Mobile Phase Filtration
  • Glove Box
  • And more

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    What CMC Services Do You Require & How Can We Help?

    Contact Us Today and find out how CMC Pharma can help you!

    Whether you’re looking for formulation development studies, analytical method development and validation, drug stability evaluation, or more, our expert team is ready to connect.

    Send us a message or give us a call at 440-485-1734