Protheragen-ING Lab provides professional DMF registration services for active pharmaceutical ingredients (API) and excipients, designed to ensure that your products meet strict regulatory standards, facilitate smooth market entry and maintain continuous compliance.
What is DMF registration?
A Drug Master File (DMF) is a detailed document submitted to regulatory authorities, such as the FDA, which contains confidential and comprehensive information about the facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. DMFs play a crucial role in supporting drug applications by providing regulatory bodies with essential information without disclosing proprietary data to the drug product applicant.
Why is DMF registration important?
DMF registration is a critical step for API and excipient manufacturers, as it:
- Demonstrates the quality, safety, and consistency of your products
- Enables you to supply your ingredients to drug product manufacturers
- Protects your proprietary information and intellectual property
- Ensures compliance with FDA regulations and guidelines
Our comprehensive DMF registration services
Our team of regulatory experts has extensive experience in DMF preparation, submission, and maintenance. We offer the following services:
Preparation and Submission of DMFs
a. Type II DMF for APIs - This involves detailed information about the manufacturing process, controls, packaging, and stability of the active pharmaceutical ingredient.
b. Type IV DMF for Excipients - This includes comprehensive data on the excipient’s properties, manufacturing processes, controls, and packaging.
Gap Analysis and Documentation Review
Our experts perform a thorough review of existing documentation and conduct a gap analysis to identify any missing or incomplete information required for DMF submission.
Regulatory Strategy and Consulting
We offer strategic guidance to ensure compliance with global regulatory requirements, including those of the FDA, EMA, and other international health authorities.
Technical Writing and Compilation
Our team of experienced technical writers compiles and formats the DMF, ensuring it meets all regulatory standards and guidelines for a successful submission.
Stability Studies and Validation
We provide support in designing and conducting stability studies, as well as validation of analytical methods, to substantiate the quality and shelf life of your API and excipient.
Regulatory Updates and Maintenance
Post-submission, we assist with updates and amendments to your DMF to reflect any changes in manufacturing processes, facilities, or quality controls.
Confidentiality and Data Protection
We understand the sensitive nature of the information contained in DMFs and ensure stringent confidentiality and data protection measures are in place throughout our service.
Benefits of our DMF registration services
- Ensures your APIs and excipients meet all regulatory requirements, reducing the risk of rejection or delays.
- Protects your proprietary information while supporting regulatory submissions.
- Leverages our extensive experience and in-depth knowledge of regulatory requirements and submission processes.
- Streamlines the DMF preparation and submission process, saving time and resources.
- Supports compliance with international regulatory bodies, facilitating global market access.
To learn more about our DMF registration services or to get started, please contact us today.