U.S. Drug Master File Document Production and Filing

Background of IND Application

As the pharmaceutical industry grows and evolves, compliance remains a key factor in bringing novel drugs to market. An important aspect of regulatory compliance is the production and filing of drug master files (DMFs) with regulatory agencies such as the Food and Drug Administration (FDA). A DMF is a voluntary submission to the FDA that provides confidential information about the manufacture, processing, packaging, and storage of one or more human drug(s). It is not required by law or FDA regulations and is submitted at the discretion of the holder. The information contained in the DMF may be used to support NDA, IND, ANDA, export application, another DMF, or amendments and supplements to any of these.

About Us

Our company offers a range of DMF document production and filing services to help our clients navigate the FDA approval process.

Our regulatory experts understand the complexities of the DMF preparation and filing process and can provide comprehensive support to ensure that our clients' DMF submissions are accurate, complete, and in compliance with regulatory requirements. Our team of experts has extensive experience in submitting and managing DMFs for drug substances, excipients, and packaging materials to the FDA and can provide comprehensive support to pharmaceutical companies throughout the DMF submission process. Our services offer a range of advantages, including expertise, timeliness, confidentiality, and compliance, ensuring a high-quality service process and a great customer experience.

Types of DMF

Our dedicated and experienced regulatory team specializes in DMF filings and has the ability to submit the following types of DMFs to the FDA:

• APIs, intermediates, materials used in the preparation of the drug, or pharmaceutical preparations
• Packaging materials/containers
• Excipients, colorants, flavors, and essences
• FDA accepted reference information

Our DMF Document Production and Filing Services

We provide our customers with services throughout the DMF lifecycle, including but not limited to:

• Preliminary preparation
• DMF basic training, including the introduction of the U.S. DMF, management systems, etc.
• Provide DMF declaration outline according to FDA's regulatory requirements
• Regulatory submission strategies for different DMF types
• Gap analysis of registration data and pre-review with drug information
• DMF preparation and submission
• Analytical testing, including elemental analysis, validation, stability, etc.
• Review, translation, preparation, and submission of registration documents in CTD format
• U.S. agent service for DMF filing
• Establish ESG submission channel
• DMF review
• Technical liaison with FDA in the review process and answering questions
• Regulatory strategy, preparation, and submission of amendments and annual reports for registered drug master files
• DMF maintenance
• Activate or deactivate DMF
• Assist the GMP department with on-site inspections if needed

Our Advantages

• Timeliness—We understand the importance of timely DMF submissions, and work closely with our clients to ensure deadlines are met.
• Confidentiality—We have strict confidentiality policies in place to ensure client information is secure and confidential.
• Compliance—Our services are designed to ensure that our clients' DMF submissions comply with all applicable regulations and guidelines.

If you need help or have a question, please feel free to contact us for more details.