Ensure Regulatory
Submission Readiness
Partnering with
BioLife Solutions
Bringing a new cell and gene therapy to market is a complex process that requires rigorous regulatory compliance. From early regulatory reviews such as Investigational New Drug (IND) applications to commercial license applications like the Biologics License Applications (BLA), each step demands detailed documentation, adherence to Good Manufacturing Practices (GMP), and strategic planning to ensure a smooth approval process.
We have supported many CGT manufacturers through this journey, helping them optimize their biopreservation and bioproduction strategies to meet regulatory requirements efficiently. By preparing early and leveraging our industry expertise, our customers can save valuable time and reduce regulatory hurdles.
Initiating Clinical Study Submission (ex. Investigational New Drug or IND)
A well-prepared application reduces the likelihood of delays and clinical holds.
Your submission should include:
In the United States, the manufacturing and quality details for a clinical study are captured within the Chemistry, Manufacturing, and Controls (CMC) section of the regulatory submission. This is often where BioLife Solutions can help. We have extensive experience supporting global regulatory filings, and in the U.S. we can provide a Letter of Authorization (LOA) granting access to our Drug Master Files (DMFs) with the U.S. Food and Drug Administration (FDA).
Please consult your internal regulatory team for submission-specific guidance.
Advancing to Commercial Approval (ex. Biologics License Application or BLA)
After successful completion of clinical trials, manufacturers may submit a BLA or equivalent submission to seek approval for commercial distribution.
This submission will likely include:
- Comprehensive safety and efficacy data
- Manufacturing and quality control details
- Labeling and pharmacology information
A well-prepared submission can minimize the risk of delays or clinical holds. However, always consult your internal regulatory team for guidance specific to your program.
BioLife Solutions has supported regulatory filings worldwide, and in the United States we can provide a Letter of Authorization (LOA) granting regulatory agencies access to our Drug Master Files (DMFs) with the U.S. Food and Drug Administration (FDA). When additional or detailed questions arise, our team is available to help address those inquiries. We understand that deeper regulatory review may surface new considerations, and we have experience supporting sponsors through that process.
The importance of Good Manufacturing Practices (GMP) compliance
Expectations for Good Manufacturing Practices (GMP) evolve as a therapy advances through clinical and commercial stages. From a manufacturing standpoint, regulators are looking for evidence of process control and the confirmation that you not only understand your process but can consistently reproduce it.
In early-phase (Phase 1) development, GMP expectations focus on documentation: demonstrating that you are following a defined process. By the commercial stage, those expectations expand to include documented proof that the process is controlled, reproducible, and continuously verified. This applies to every component of manufacturing. From how you select and qualify your tools and materials, to how you confirm that suppliers provide the right materials every time. Each layer adds control and confidence.
While full GMP compliance may not be required for IND submissions, establishing a robust and repeatable manufacturing process early can greatly streamline regulatory approvals later. GMP becomes mandatory for BLA submissions, ensuring biologics are consistently produced and controlled to meet defined quality standards.
At BioLife Solutions, our products are manufactured under certified quality systems with documented processes and defined specifications. We understand the rigor required at each phase. As your partner and supplier, we design and control our products to meet your expectations for consistency, compliance, and quality.
Master Files: streamlining your regulatory submission
A Master File provides proprietary information about raw materials and manufacturing processes to regulatory agencies, helping expedite approvals.
BioLife Solutions maintains FDA Master Files for key biopreservation and bioproduction processes, including:
By referencing our Master Files, drug manufacturers can limit additional regulatory inquiries and streamline submission approvals.
Global regulatory support
While the US FDA accepts Master Files, European and Japanese regulatory agencies require alternative documentation. BioLife Solutions provides quality and compliance support for customers submitting applications worldwide.
How can BioLife
Solutions can help?
Do you need regulatory
support?
Our team is committed to supporting CGT manufacturers at every stage of regulatory submission. By leveraging our expertise in biopreservation, closed-system manufacturing, and quality control, we help customers navigate complex regulatory landscapes with confidence.
Do you have
other questions?
At BioLife Solutions, we’re dedicated to accelerating the development of life-saving therapies while ensuring compliance with global regulatory standards.
Let us know what we can help you with.
