CMC Consulting

ACCESS INTERIM TALENT FOR CRITICAL CMC CONSULTING PROJECTS

To meet time-sensitive and specialized requirements of Chemistry, Manufacturing and Controls (CMC) projects, many pharma and biotech companies turn to highly-skilled and experienced CMC regulatory consultants on an interim staffing basis.

Klein Hersh stands ready to assist with your CMC consulting needs through our unmatched talent network that provides access to proven CMC executives. Leverage our trusted expertise as CMC recruiters to identify tenured consultants who can support your drug development programs through regulatory submission management, dossier authoring, CMC documentation, marketing authorization application (MAA) development, and CMC coordination needs.

Executive Chemistry Manufacturing and Control Recruiting Specialists

If you need a CMC consultant to fill an interim project need, Klein Hersh is uniquely qualified to assist. For over 20 years, we’ve built relationships with experienced CMC regulatory executives throughout the U.S. and can leverage our unparalleled network to deliver a high quality, flexible staffing model to your organization.

Klein Hersh delivers unique value as CMC recruiters

Klein Hersh draws upon our large pool of active CMC regulatory consultants to rapidly fill your immediate needs. We add further value by connecting you to specialized professionals who have the exact skills you require for your unique project needs and regulatory requirement and know what it takes to succeed on an interim assignment.

Let Klein Hersh help you address a wide range of short term CMC projects including:

Regulatory Submission Management
Engage proven CMC regulatory consultants to lead or support regulatory filings of developmental or approved products and respond to questions from regulatory bodies.
Dossier Authoring
Gain experienced interim talent to create CMC documentation for regulatory submissions, including characterization of the API (active pharmaceutical ingredient) of drugs.
Marketing Authorization Application (MAA) Development
Tap into trusted expertise for compiling information required for MAA completion, including composition of the dosage form, raw materials used in product manufacturing, description of the manufacturing process, and stability data.
Chemistry Manufacturing and Controls Coordination
Harness proven industry experience to manage the collection and transfer of documentation from R&D and other scientific, technical, quality and commercial areas within the company, as well as external contract research organizations (CROs), involved in the drug development process required to produce dossiers for submission filing.

Why Partner with Klein Hersh:

  • Tap into a deep network of proven CMC consultants.
  • Gain highly-specialized CMC consulting expertise to fill interim staffing needs.
  • Leverage on-demand access to top regulatory affairs talent.
  • Solve short term CMC needs easily and cost-effectively.
  • Support regulatory requirements with current knowledge of Chemistry, Manufacturing and Controls best practices.

To learn more about our interim staffing and consulting services, please contact:

rsz 2zachZachary Spitz
Senior Director, Regulatory Affairs
267.948.1429
zspitz@kleinhersh.com