CMC and Scale-Up; Chemistry Manufacturing and Controls

Satisfy Regulatory Authorities

Our integrated services across drug substance, particle engineering and drug product incorporate the appropriate CMC activities to help you meet global regulatory requirements.

Access CMC activities

To produce a 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.

Dedicated In-House Experts

We excel in writing and facilitating responses to questions raised by global health authorities for clinical trial and license applications

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

In close collaboration with you, our Regulatory Affairs team will write a phase appropriate CMC dossier to support the clinical development of your drug product. Our team excels in writing and facilitating responses to questions raised by global health authorities for clinical trial and license applications.

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 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.

Meet the expert

Jakob Bonde serves a Head of Regulatory Affairs, Small Molecules, at Lonza’s site in Visp, Switzerland, advising internal and external global customers on regulatory compliance and writing and reviewing Chemistry, Manufacturing and Controls (CMC) documentation for drug substances and drug products. Before joining Lonza in 2018, Jakob held Regulatory Affairs and Quality CMC positions in Pfizer, J&J/McNeil, Grünenthal, Mondobiotech, Medpace, and Clinipace. His areas of expertise include CMC writing and change control; clinical development consulting in typical and accelerated procedures; and global clinical trial start-up for chemical entities, biologics, and advanced therapy medicinal products (ATMPs).

Jakob Bonde

Head of Regulatory Affairs, Small Molecules

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Related Offerings

Regulatory Affairs CMC Services for Small Molecules

We can support your accelerated regulatory pathways and special designations for small molecule and...

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Regulatory expertise

Pathway to success in Regulatory filings

Extensive Regulatory Expertise

We offer our in-depth expertise in the interpretation of legal requirements and guidance in innovative and emerging markets. Our regulatory affairs CMC experts are co-located alongside subject matter experts at our manufacturing sites around the globe. Our team has extensive experience in CMC dossier writing as well as preparing responses to questions from health authorities across the world.

Dedicated Regulatory Affairs Contact

We ensure that each project has one dedicated regulatory affairs point of contact who, in partnership with you, will develop and finalize a regulatory CMC strategy. The strategy will ensure you have the required data to support global applications.

Keep Pace with Regulatory Thinking

Our Regulatory Affairs Services prioritize transparent communication. We ensure that you are continuously informed from kick-off and during subsequent interactions, facilitating any CMC development strategy or detailed discussions.

Small Molecules