From pre-clinical CMC strategies to regulatory filings and post launch process improvement efforts, the Sterling CMC team offers rich technical guidance and regulatory support throughout the entire product lifecycle.
Chemistry, Manufacturing and Controls (CMC) support at Sterling
Maintaining quality and safety throughout an API’s entire lifecycle, from discovery through to commercialisation, is critical to its continued success. At Sterling, our Chemistry, Manufacturing and Controls (CMC) services team works closely with customers from pre-clinical through to post-launch, providing guidance and expertise on technical and regulatory considerations. ... Read more
Our team will work with you in whatever capacity best suits your needs, from defining your CMC strategy to building out the CMC section of your regulatory submissions. We make sure your drug substance and process parameters are solid and clearly defined, and that our teams adhere to them throughout your entire project. Together, we will develop a robust CMC approach that stands up to scrutiny. Read less
What is CMC?
Chemistry, Manufacturing and Controls (CMC) involves defining manufacturing processes, molecule characteristics, and intermediate testing through each phase of the molecule’s lifecycle to ensure continued quality, consistency, and regulatory compliance. Regulatory authorities require CMC submissions to validate product and process quality as an API moves through clinical trials.
Our CMC services team is wholly dedicated to ensuring your product and process’ quality and compliance.
Our team has extensive knowledge of regulatory requirements around the world, including the US, UK, EU, Japan, and Canada.
We support your CMC requirements from discovery to commercialisation, from pre-clinical through post-launch.
Outstanding safety and compliance:
We uphold stringent HSE standards in line with our ZeroHarm initiative to ensure that products are produced safely for both people and planet.
Full-lifecycle CMC support
With more than 50 years of expertise in API development and manufacturing, we are committed to upholding stringent global standards for quality, safety, and compliance. We have worked with customers across the globe to meet regulatory requirements and deliver exceptional, repeatable quality in their products and processes.
Discover how we provide CMC services throughout each phase of your product’s lifecycle.
It is critical to consider regulatory and quality requirements during the discovery stage of a new drug candidate, known as an IND (Investigational New Drug) in the US and an IMP (Investigational Medicinal Product) in the UK, to position your molecule for success throughout its lifecycle.
During discovery, we work to define an appropriate CMC strategy for your programme. While we understand the importance of getting a product to clinical trials as quickly as possible, we also know the comprehensive data required to gain regulatory approval. As a result, we work closely with our customers to shape a CMC strategy that strikes an optimal balance between speed, cost, and regulatory success.
To support successful regulatory submissions, we offer:
- Outlines of the manufacturing process: We deliver detailed descriptions of each stage in the manufacturing process, including relevant diagrams and isolation and purification methods in support of 3.2.S.2 (Manufacture) section of the CTD Module 3 submission.
- Control of Materials: Quality materials are crucial to developing quality product. We provide detailed recommendations for raw materials and process intermediates in support of 3.2.S.2.3 (Control of Materials) section of the CTD Module 3 submission.
- Characterisation of Drug Substance: We detail your drug substance in accordance with filing expectations for 3.2.S.3.1 (Elucidation of Structure) and 3.2.S.3.2 (Impurities) of the CTD Module 3 submission.
- Quality Control of Drug Substance: We deliver comprehensive analytical data around identity, purity, and potency, as well as impurity identification, characterisation, and synthesis services in support of 3.2.S.4 (Control of Drug Substance) for CTD Module 3 submission.
Even when CMC is effectively addressed in the preclinical phase, successfully moving a drug candidate through early critical trials is increasingly difficult. During this important phase of the pharmaceutical lifecycle, CMC is exceedingly critical.
During phase I and II, our CMC team works closely with you to carefully determine parameters for quality and regulatory success during the long and complex clinical trial process. In addition, we provide strong support in Regulatory starting material (RSM) selection, impurities assessments, and tolerance analysis.
Our phase I and II CMC services include:
- Regulatory Starting Material (RSM): Prior to phase III clinical trials, we help you develop and identify an appropriate regulatory starting material, while ensuring manufacturing processes will remain GMP-compliant.
- Potential Genotoxic Impurities Assessments: Our assessments align with M7 requirements and enable us to identify any potential genotoxic impurities that may require both manufacturing and detection controls.
- Fate and Tolerance of Impurities: We investigate any impurities that form throughout your product’s manufacturing processes, then develop additional controls to ensure purity based on your API’s tolerance to purification processes.
NDA submissions follow successful phase III trials. Composing a thorough NDA submission involves significant data collection and close attention to detail. At Sterling, we have successfully navigated the complex NDA submission process requirements for pharmaceutical organisations of all sizes.
As a natural requirement of our API manufacturing capabilities, we offer robust process validation services that generate the required data to support your NDA submission. Our CMC team has extensive expertise in reviewing this data and compiling the CMC sections of your NDA filing.
After commercial launch, the importance of CMC continues in the form of continual process improvement. As a full-lifecycle partner, our CMC team assists in post-approval process improvements, enhanced test methods, new vendor onboarding, and alternative route investigations for cost-effective second-generation API manufacturing.
If there is any change to your manufacturing process, our experts provide the data and justification necessary to ensure your drug’s approval is not impacted.
Our post-launch support offerings include:
- Process improvement recommendations
- Validation of improved test methods
- Investigations into alternative routes of synthesis for RSMs and APIs
- Data, justification, and documentation for changes
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