Strategic Development Support
Partner with us to obtain scientific advice, regulatory strategy, meetings with regulators, information requests and post approval work.
Regulatory Submissions
We offer phase-appropriate guidance and interpretation of the guidance. We can write and/or review CMC sections of clinical applications (e.g. IND/IMPD) and license applications (BLA/NDA/MAA) and support clients by writing and/or reviewing responses to agency questions.
Global Markets Registration
We provide post-approval changes and can prepare variations for product lifecycle maintenance.
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 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.

employees in Portsmouth 

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.


Strategic support• Pre-IND meeting strategic support• GMP gap assessment• Scientific advice (briefing book)• Agency meeting support• Regulatory strategyIMPD/IND, Clinical trials• Draft and/or review CMC sections of the filing• Summarize and/or review CMC information• Draft and/or reviewresponse to HA questions during the review cycle• Compatibility assessment support• Scale-up/out• Technology transferMAA/NDA/BLA• Provide detailed CMC information (eCTD ready)• Respond to questions• Pre-approval inspectionLifecycle support• Variations• Follow on ROW submissions• Product quality reviewsPre-clinicalClinical trial applicationClinical trial applicationMarket license applicationPost-approval changesMarketClinical trialsApproval

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.