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Petri Dishes with Experiment

Chemistry, Manufacturing, & Controls (CMC) Writing & Strategy

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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: 

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AgileWriter.ai™

First-in-class AI tool for composing and managing clinical trial documents

 › ​Learn more

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Quillyx™

eCTD templates that pass technical validation of submissions

 › ​Learn more

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VeriSync™

Co-authoring sync monitoring tool for Microsoft Word

 › ​Learn more

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.

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