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Regulatory Compliance for Critical Materials in CGT

ACROBiosystems conducts in-depth research on domestic and international (especially China and the United States) CGT industry raw material-related regulations and standards. At the beginning of GMP product design and development, we integrate various regulatory requirements into our GMP product design inputs, aiming to create "truly GMP-grade" raw materials that meet global regulatory requirements and better assist CGT drug clinical/marketing applications.

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FDA DMF Filing Support

ACROBiosystems GMP-grade products have completed FDA DMF filing (some are in the process of filing). If your drug project uses our DMF-filed GMP products and is in the clinical application or new drug registration regulatory filing stage, you can directly reference our DMF number, thereby saving product review and evaluation time and reducing preparation work for new drug clinical applications. If you have relevant requirements, please submit an authorization application to ACROBiosystems. After receiving the application, we will provide a DMF authorization letter to the FDA center.

RSF Documents Support

We have summarized the key qualification requirements for GMP-grade raw materials used in cell/gene therapy based on domestic and international cell therapy-related regulations and customer or official requirements, and carefully prepared them into RSF (Regulatory Support Files) to meet the application needs of customers at different stages. What you care about is what we focus on!

ACROBiosystems' RSF documents are divided into two levels: Level 1 documents are product qualification documents, and Level 2 documents are unique quality and safety documents. They respectively assist customers at different stages to successfully apply.

Level 1 Documents (Product Qualification Documents, Free)

Focusing on customers in the research or pre-clinical stage, at this stage customers are in the material screening phase, our Level 1 documents can serve as sufficient supplier qualification proof and product introduction documents for customers' procurement and QA. Our Level 1 documents serve as necessary proof documents for the new supplier admission stage.

- Product Introduction and Applicable Regulations

- Quality certificate and qualification documents

- Quality Certificate for Key Materials and Consumables

- Production process description

- Cell line detection for COA

- Main production equipment

- Quality Inspection Standards

- Analysis method basis

- COO

- No TSE/BSE/AOF declaration

- Stability

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- About 40-60 pages

Level 2 Documents (Unique Quality and Safety Documents, Paid)

Customers beginning the clinical process, at this stage customers need more detailed raw material information to support their clinical applications or market authorization. Our Level 2 documents include detailed quality inspection method SOPs and analytical method validation reports, which undoubtedly save customers a lot of time, cost and manpower in analytical method development and validation for customers who need to establish strict material admission standards. Strict material control strategies and detailed material safety testing reports can also help customers shorten application time and reduce the risk of supplementary submissions.

- Complete detection report of main cell bank

- Supplier Qualification and Audit Report

- SOP for Analysis Method Testing

- Analysis Method Validation Report

- Raw data report for safety testing: Mycoplasma/virus/abnormal toxicity/acute toxicity, etc.

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- 1000+ pages

IND/BLA Stage Compliance Support

During the IND/BLA application process, we can provide free online or on-site support to help customers respond to regulatory agency questions related to raw materials, assisting in the success of customer applications!

ACROBiosystems has a mature and professional regulatory support team that has assisted 14+ customers in China, the United States, South Korea and other regions in completing multiple CDE, FDA, and KFDA applications, accumulating rich application experience. We can provide comprehensive two-level RSF documents and full product line DMF filing to meet the usage and application requirements of customers at different stages. ACROBiosystems provides you with the highest quality GMP products and the most comprehensive regulatory support documents, continuously safeguarding your drug application journey.