Dedicated regulatory professionals
We work closely with our internal and external customers is to provide leadership, guidance, and expertise to customers on regulatory matters throughout the life cycle of your biologics drug product.
Our dedicated biologics 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 biologics drug products.
Regulatory Affairs CMC requirements
Our biologics regulatory 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 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 biologics drug products
our regulatory affairs services are working 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 Compliance
Navigating the changing regulatory landscape
Regulations within the biologics 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 bench to bedside.
The biologics regulatory affairs department are experts in keeping track of the 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.