The Backbone of Drug Applications
CMC documentation forms the backbone of any drug application. Health authorities scrutinize Module 3 content to ensure your product can be manufactured consistently, meets quality specifications, and will remain stable throughout its shelf life.
RegOps CMC writers combine deep pharmaceutical science knowledge with regulatory writing expertise. We understand the technical details—synthesis routes, analytical methods, process parameters—and we know how to present them in ways that satisfy regulatory reviewers. Our documentation supports your manufacturing reality while meeting the documentation standards that health authorities expect.
Our Capabilities
Comprehensive CMC documentation support.
Complete authoring of drug substance sections including manufacture, characterization, control, and stability. We document synthesis and quality attributes comprehensively.
End-to-end drug product documentation covering composition, pharmaceutical development, manufacture, control of excipients, container closure, and stability data.
Clear descriptions of analytical procedures for identity, assay, and impurities. We ensure methods are described with sufficient detail for regulatory review and technology transfer.
Manufacturing process narratives describing unit operations, critical parameters, and validation protocols. We balance completeness with protection of proprietary information.
Authoring of stability protocols, reports, and shelf-life justifications aligned with ICH guidelines. We present data in formats that support proposed storage conditions.
Technical documentation supporting manufacturing changes, site transfers, and scale-up. We author comparability protocols demonstrating equivalence across change scenarios.
The RegOps Advantage
We combine scientific fluency with regulatory expertise to create robust CMC sections.
Cross-Functional Fluency
We communicate effectively with scientists and engineers, enabling accurate documentation of complex technical content.
Lifecycle Perspective
We author documentation with future submissions in mind, establishing a foundation that supports post-approval changes.
Modality Experience
Our experience spans small molecules, biologics, and advanced therapies. We understand modality-specific expectations.
Regulatory Alignment
We stay current with evolving CMC guidance from FDA, EMA, and ICH, ensuring your documentation reflects current expectations.