Chemistry, Manufacturing, & Controls (CMC) Writing & Strategy
Our Expertise in Action
A well-defined Chemistry, Manufacturing, and Controls (CMC) strategy is essential for regulatory success and efficient product development. Our CMC Strategy and Writing services ensure that your manufacturing and quality data are clearly documented, compliant with global regulatory expectations, and aligned with your product’s development and commercialization goals. Whether you need strategic guidance, regulatory support, or expert technical writing, we help you navigate the complexities of CMC documentation with precision and efficiency.
CMC Writing & Strategy Services
CMC regulatory strategy and planning
Analytical method development and validation summaries
Comparability and justification of specifications
CTD authoring and gap analysis
Stability study design and reporting
Technology transfer documentation
Drug substance and drug product development reports
Manufacturing process descriptions and controls
CMC lifecycle management and post-approval changes
Technology Solutions
We are thought leaders on the use of automation/logic-based programming and AI for patient data and patient-facing documents. Innovations include:
AgileWriter.ai™
First-in-class AI tool for composing and managing clinical trial documents
Synterex also is a Microsoft Cloud AI Partner, which positions us to work closely with product management at one of the largest tech companies in the world to advocate for clients and deliver best-in-class user experiences.
Learn more about how we're leveraging technology for the good of the patient.