Dedicated regulatory professionals
We work closely with our internal and external customers to provide leadership, guidance, and expertise on regulatory matters throughout the life cycle of cell and gene therapy products.
Our global cell and gene therapies regulatory team has established expertise 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 cell and gene therapy products.
Regulatory needs in the cell and gene therapy space
Our regulatory cell and gene therapy offering is customized to support you at each critical time and milestone as your therapy progresses through the regulatory pathway towards commercialization.
Partner with us to help identify the appropriate number of runs prior to IND/IMPD filings and PPQ to support the success of your filings. We will also work to anticipate and be prepared for facility and equipment questions and audits.
Get support at each step of your regulatory pathway, with the right, scaled service to meet your needs.
Shaping the regulatory framework for cell and gene therapy products
In the evolving field of cell and gene therapy, regulatory support requires keeping up with regulatory trends. We do this through our active involvement in regulatory conversations in various industry groups, as well as routine regulatory intelligence to identify opportunities in commenting on proposed regulatory guidance and regulations.
We sponsor the Alliance for Regenerative Medicine (ARM) and its legislative fly-in meeting. Here we leverage our practical experience to advocate for favorable regulation.
Regulatory Support for the Lonza Cocoon® Platform
Lonza has dedicated regulatory staff available to assist customers with the provision of technical and compliance information related to the Cocoon® Platform. We have developed ready-to-go Support Packages with all the necessary information required to support incorporation of the Cocoon® Platform into your Regulatory Submissions.
In the US, a Type V Drug Master File is registered with the FDA and may be referenced via a Letter of Authorization upon request. For non-US customers, Lonza is able to provide a Product Dossier summarizing key information about the Cocoon® Platform to aid in preparation of your Regulatory filing.
| Support | Level 1 - Available to All Our Customers | Level 2 - Beginning the Clinical Journey | Level 3 - Becoming a True Partner |
|---|---|---|---|
| Change Notifications | |||
| Material Statements | |||
| Instructions/Tech Sheets | |||
| Paper Audit Documentation | |||
| Assistance referencing Drug Master File | |||
| Product Dossier | |||
| Process Validation Overview | |||
| Quality Agreements | |||
| Supply Agreements | |||
| In-Person Audit | |||
| Regional Specific Support | |||
| Customized support with regulator inquiries | |||
| Submission CMC Section Review | |||
| Comparability Protocol Review |
Regulatory Compliance
Navigating the changing regulatory landscape
Regulations within the cell and gene therapy industry are constantly changing as scientific research and innovative approaches to product development are advancing rapidly. Lonza operates within a global market working with a wide variety of customers at all stages of product development from bench to bedside.
The cell and gene therapy regulatory affairs department are experts in keeping track of the ever-changing legislation in all regions where 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.