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.
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.
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.
Subject Matter Expert: First-in-Human
Interview with Jakob
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.
Regulatory CMC Compliance
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.