Regulatory Support
Our regulatory, quality, and product teams bring deep expertise in the requirements for ancillary materials used in cell and gene therapy development. With over 19 years of experience, we help developers navigate the approval process by providing FDA Master Files for our key cytokines, growth factors, media supplements, and human plasma derived products along with comprehensive documentation and guidance aligned with current regulatory standards.
As the first in the industry to offer FDA eCTD Master Files, Akron continues to lead with an innovative mindset-constantly evolving our support to meet the needs of our customers.
Quality Compliance
We provide the following regulatory support for our customers:
- Remote or onsite auditing of our production sites upon request (with Quality Agreement)
- Regulatory Support Files, BSE/TSE Certificates (upon request)
- Change notifications prior to product changes (with or without Quality Agreement)
- Drug Master Files for cross-reference (USA & Canada only)
What is a Master File (MF)?
An MF provides detailed, confidential information about a product’s manufacturing, processing, packaging, and storage, including chemistry, raw materials, stability, purity, and more. Master Files are used to support an Investigational New Drug (IND) application, Biologic License Application (BLA), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or another MF. MFs enable manufacturers to protect intellectual property by allowing regulators at the FDA to review the contents of the MF in support of a third party’s submission. In line with the FDA’s submission requirements, Akron submits MFs (Type II) in electronic common technical document (eCTD) format.
USA & Canada Master
We’ve created eCTD Master Files for our top selling cGMP ancillary materials for use with the US FDA. Additionally, we have an MF Type I on file with Health Canada for our rHu IL-2 product line.
Our Available eCTD MFs
Referencing our MFs in regulatory filings
The FDA can cross-reference our MFs in conjunction with your IND, BLA, NDA, or ANDA. A cross-reference can be initiated via a request for a Letter of Authorization (LOA). Health Canada can also cross-reference our MF Type I filed for rHu IL-2.
The LOA is a written statement by the MF holder permitting these agencies to refer to information in the file in support of another organization’s submission.