Have your CMC production activities satisfy regulatory authorities

To produce a pharmaceutical dosage form, manufacturing processes, product characteristics, and product testing must be specifically defined to ensure that the product is safe, effective, and of consistent quality. Successful delineation of these chemistry, manufacturing, and control (CMC) activities is a crucial part of the product-development lifecycle. Our integrated services across drug substance, particle engineering and drug product incorporates the appropriate CMC activities to satisfy global regulatory authorities.



Get a CMC dossier suitable to the stage of clinical development of your product

In close collaboration with you, our Regulatory Affairs team will write a CMC dossier suitable to the stage of clinical development of your drug substance or drug product manufactured by Lonza. This extensive and dedicated team excels in writing and facilitating responses to questions raised by global health authorities for clinical trial and license applications.

This presentation will cover phase-appropriate development approaches and supply chain solutions for integrated drug substance and drug product projects that can accelerate program timelines and reduce overall complexity and risk.

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Avoiding CMC failures through phase-appropriate clinical development and supply chain setup

Get a CMC dossier suitable to the stage of clinical development of your product

In close collaboration with you, our Regulatory Affairs team will write a CMC dossier suitable to the stage of clinical development of your drug substance or drug product manufactured by Lonza. This extensive and dedicated team excels in writing and facilitating responses to questions raised by global health authorities for clinical trial and license applications.

Our CMC capabilities throughout product development

Our expertise in CMC development will help you satisfy the regulatory requirements of authorities worldwide. Our scientists and engineers carefully assess the physicochemical properties of the drug compound and identify the optimal enabling technologies and dosage form, for oral (capsules and tablet formats), inhaled, injectable, or intravenous drug delivery. Then, we carefully optimize the manufacturing process, ensuring that product characteristics remain consistent as the manufacturing process is scaled up.

Streamline CMC product design and development

Our proprietary technology-selection methodologies, predictive models, reference tools, flow-chart methodologies, testing methods and process equipment enable streamlined product design and development and smooth progression through all development stages. At each stage of development, we work together with you to identify the critical-to-quality attributes and important formulation and process parameters. A robust control strategy is implemented to ensure a quality-by-design (QbD) approach and seamless scale-up to commercial manufacture.

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