Will your Chemistry, Manufacturing and Controls (CMC) documentation meet complex regulatory compliance standards?
Cardinal Health Regulatory Sciences has the qualified scientific and medical writing expertise to ensure that your Chemistry, Manufacturing and Controls (CMC) documentation is complete, and that it tells the right story.
We partner with you to develop your regulatory strategy, and to author, prepare, review and submit CMC documentation for all phases of development. At each clinical phase and commercial launch, we ensure that your drug product meets the complex regulatory compliance and quality standards of the FDA and global health authorities.
Our suite of CMC services includes
- Preparing, reviewing and maintaining your regulatory documents – including Drug Master Files – for the United States, Canada, Europe and other regions
- Leading complete analytical and formulation development programs for small molecules, biologics, medical devices and products in all major dosage forms
- Serving as the regulatory point-of-contact between you and the FDA
- Providing technical guidance for analytical method development and process validation; and for formulation and process development
- Managing clinical trial material production
- Providing a broad range of additional regulatory guidance
Get it right the first time
Contact us to discuss how we can support your CMC strategy. Your product’s timely approval depends on it.