DMF Compilation & Submissions
The Drug Master File (DMF) is a document submitted to regulatory authorities by pharmaceutical companies to provide confidential, detailed information about a specific aspect of a drug substance, drug substance intermediate, or excipient that is used in the manufacturing of a drug product. The information contained in a DMF is considered confidential and is protected under regulations in the US and EU.
A DMF compilation is the process of collecting and organizing the information that is required to be included in the DMF. This information includes details such as the chemical and physical properties of the drug substance, manufacturing processes, quality control procedures, and stability data.
DMF submission is the process of submitting the completed DMF document to the relevant regulatory authority for review and approval. The purpose of the submission is to provide information about the drug substance to support the approval of a drug product that contains it. The submission process may include additional rounds of review and communication with the regulatory authority, as well as the provision of additional information or clarification as needed.
With over 15+ years experience, our regulatory affairs team has helped several pharma and medical device companies in compiling and submitting the DMF with the following principles:
- Ensuring accuracy and completeness of information in the DMF as per applicable regulations
- Protecting the DMF document and securely completing submissions to regulatory bodies
- Conduct regular DMF Quality Control Reviews to ensure that the document is continously updated with latest changes
- Cost-effective regulatory consulting, document preparation, quality control review, submission management, and data management services
- Leveraging latest technology for rapid content creation with pre-defined templates and documents repository
- Always meeting timelines and avoiding delays
How We Can Help
DMF Compilation
At Techsol, we have a specialized team who can help to streamline the DMF compilation and submission process, reducing the time and resources required to complete the process and increasing the chances of a successful outcome.
Our team can provide end-to-end support for preparing the following types of Drug Master Files:
> Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
Your Questions & Our Answers
There are two types of service models that your company can choose from:
Medical Writing FSP Model: Our team will take the responsibility of managing all medical writing activities for a complete clinical program or for an individual study with a cost-effective pricing structure.
Dedicated Resoucing Model: We can have specialized resources allocated for your organization to hand-hold all types of medical writing needs for a fixed duration.
We use the best of technology platforms that helps us to deliver our medical writing services through continous real-time collaboration with sponsors. Following are some of the systems we use:
Compier Medical Writing Platform: This is our proprietary 100% digital content management platform that facilitates rapid content authoring, completing real-time collaborative review and allows continous content lifecycle management. specifically for rapidly processing soft such as Microsoft Word to create documents.
Reference management software: Our Medical writers use reference management software such as EndNote, Mendeley, or Zotero to manage and organize their references.
Content management systems: If sponsors want us to use content management systems (CMS) like Veeva Vault, Documentum or Sharepoint, our team is familar with how to store and manage documents, track versions, and facilitate collaboration between different team members.
Typesetting software: Medical writers use typesetting software such as LaTeX or InDesign to create well-formatted documents, such as scientific publications and regulatory documents.
Medical Terminology software: Medical writers use medical terminology software such as SNOMED, ICD-10, or MedDRA to ensure accurate and consistent use of medical terms.
With the use of advanced technology and quality-driven processes, our medical writing team members collaborate with Biostatistics, Medical Affairs, Drug Safety and Clinical Data Management teams to deliver accurate and purposeful publications and other medical content with a quick turnaround with 100% compliance to global regulatory requirements. Every medical writing project is meticulously managed and delivered with stringent scientific, statistical, editorial and quality control review.
