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> Regulatory Compliance for Critical Materials in CGT 
When it comes to our Good Manufacturing Practice (GMP) products, we performed extensive research on the global regulations and standards pertaining to raw or ancillary materials before production. This means from product inception to commercialization, consideration of regulatory requirements has been incorporated into the material design. Therefore, our ancillary materials meet the highest GMP standards mandated by regulatory bodies across the globe.
We actively support Drug Master File (DMF) filing, a comprehensive set of documents containing information on product chemistry, manufacturing, and controls (CMC) information. As the first company to secure FDA DMF filing for recombinant protein reagents, we continue that support across our GMP products and other recombinant proteins. If you have any relevant requirements, please submit an authorization application to ACROBiosystems. After receiving the application, we will provide a DMF authorization letter to the FDA center.
At the forefront of our capabilities is the careful compilation of Regulatory Support Files (RSF), aligning seamlessly with international regulations and specific customer or official requirements. These documents meticulously outline the indispensable qualifications required for GMP-grade materials in CGT production, custom-tailored to meet the diverse needs of customers across various developmental stages.
The Level One documents, focusing on product qualifications, are provided free of charge to customers who have purchased GMP products. These documents, approximately 40-60 pages, are designed to serve the needs of customers in the research and pre-clinical stages. They act as essential proof of supplier qualifications during the material screening phase.
- 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
- Product COA
- COO
- No TSE/BSE/AOF declaration
- Stability
- About 40-60 pages
Level Two documents are defined as unique quality and safety documents, comprising over 1000 pages. These documents are available for purchase and target customers entering the clinical phase. At this stage, customers require detailed information on raw materials to support their clinical applications or market authorization. Level Two documents include thorough Standard Operating Procedures (SOPs), analytical method validation reports, and contribute significantly to saving time, costs, and manpower in material analysis development and validation.
- 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.
- 1000+pages
We also provide on-site support to customers throughout the IND/NDA/BLA filing process. This support encompasses addressing regulatory queries related to ancillary materials, ensuring that our customers have the correct documentation needed for their filings.
ACROBiosystems has a mature and professional regulatory support team that has assisted 14+clients in China, the United States, South Korea, and other regions in completing multiple applications for CDE, FDA, and KFDA, accumulating rich experience in application. We can provide comprehensive two-level RSF documents and DMF filing for all products to meet the usage and declaration 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 process.
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