Access specialized interim talent for unique regulatory projects
If you need a Chemistry, Manufacturing and Controls (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 executives throughout the U.S. and can leverage our unparalleled network to deliver a high quality, flexible staffing model to your organization.
Klein Hersh draws upon our large pool of active CMC 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 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:
- Lead or support regulatory filings of developmental or approved products and respond to questions from regulatory bodies.
- Create CMC documentation for regulatory submissions, including characterization of the API (active pharmaceutical ingredient) of drugs.
Marketing Authorization Application (MAA) Development
- Compile 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.
- 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 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 filings with current knowledge of CMC best practices.
To learn more about our interim staffing and consulting services, please contact:
Senior Director, Regulatory Affairs