In March 2011, Covance introduced a comprehensive and integrated set of Chemistry, Manufacturing & Controls (CMC) Pharmaceutical Development Services (PDS). Through this offering, we are committed to helping pharmaceutical companies reduce the time required to prepare IND or NDA submissions, improve the hit rate of molecules and increase the likelihood of application approval on the first pass.

How does the Covance advantage benefit you unlike any other contract service provider?

• The advantage of top-five pharma expertise. The Covance CMC PDS portfolio is built on the scientific expertise, state of the art facilities and centers of excellence of a top five pharmaceutical company.
• Comprehensive CMC development capabilities. Covance offers services for every stage of your development. This includes API development, preformulation, formulation, regulatory, analytical, technology transfer and IND/CTA-enabling CMC package.
• Trustworthy service through decades of excellent track record. Both our new and existing capabilities are built on a solid foundation of decades of established team synergy and experience.
• Unique and industry-leading specialty capabilities, including
  • Physical properties characterization and design
  • Inhalation
  • Extractables and leachables
  • Impurity isolation and identification
  • Method development and structure elucidation
  • Drug product reference standard and GMP analysis of radiolabeled clinical trial material (CTM) for human AME studies

You can choose to work with us on individual projects, milestone-based packages or full drug development solutions, whichever best fit the needs of your company and your molecule.

For large molecule CMC analytical, development and biotechnology specialty services, please click here.