Regulatory Affairs CMC Services for Small Molecules

Strategic and Technical Support:

Partner with us for strategic support for investigational medicinal product and commercial tech-transfer manufacturing and obtaining Scientific Advice (briefing book). We are actively involved in shaping and influencing the regulatory landscape to the benefit of Lonza and customers via participation in industry interest organizations.

Phase-appropriate Clinical Trial CMC Support:

We excel in guiding and writing clinical trial CMC documentation such as US IND's or European IMPD's. We have gained extensive experience having submitted multiple applications for Lonza manufactured drug substance and drug products each year. Partner with us to obtain scientific advice by participating in meetings and/or let us help you with formulating manufacturing challenges and responses.

Commercial applications:

We offer writing module 3 commercial applications in a eCTD compliant submission-ready format such as a BLA, NDA or MAA, for direct submission by clients or partly via a Lonza submitted ASMF and/or DMF. We can also provide global registrations or post-approval provision for applications requiring submission of supporting GMP certificates, eBR, MBR and/or SMF to support applications.

External Influencing:

We are actively involved in industry groups to contribute and shape the regulatory landscape.

Dedicated regulatory professionals

We work closely with our internal and external customers to provide leadership, guidance, and expertise to internal and external customers on regulatory matters throughout the life cycle of your small molecules drug product.

Our dedicated small molecules regulatory team consists of highly experienced globally based experts with previous experience in operations, QA, QC, and process development. Our broad range of experience enables us to provide you with an excellent understanding of regulatory requirements for your small molecule drug products.

Regulatory Affairs CMC Services

Our small molecules offering is customized to support you at each critical time and milestone as your therapy progresses through the regulatory pathway towards its commercialization.

Partner with us to help identify the phase appropriate information required prior to IND/IMPD filings and timing of PPQ batches to successfully file your commercial application. We will also work to anticipate and be prepared for facility questions prior to inspections or audits.

Get support each step of your regulatory pathway, with the right, scaled service to meet your needs.

Shaping and influencing the regulatory framework for small molecules drug products

Our regulatory affairs services work within industry organizations to support and propose innovative solutions that will facilitate a more scientific pathway to accelerate clinical drug candidates and to mitigate interpretation difference of documentation requirements for global drug products in the commercial approval processes.

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.

Regulatory CMC Compliance

Navigating the ever changing regulatory landscape

Regulations within the small molecules industry are constantly changing as scientific research and innovative approaches to product development are advancing. Lonza operates within a global market, working with a wide variety of customers at all stages of product development from early development projects to commercial global rollout.

The small molecules regulatory affairs CMC experts are keeping track of changing legislation in all the regions in which Lonza operates. We provide guidance to our customers worldwide and offer a broad range of RA capabilities to add value for new and existing customers during their product journey.