With the evolution of pharmaceutical industry over the past decades, compliance remains a key factor in bringing novel drugs to market. Proregulations, as a product safety and regulatory consulting firm with a long-standing core mission of "Value in Compliance", announces to offer a series of DMF document production and filing services, helping clients worldwide navigate the FDA approval process in a faster and safer manner.
Before a new drug enters the market, its manufacturers would voluntarily submit drug master files (DMFs) to regulatory agencies like FDA. The DMFs generally provide confidential information about the manufacture, processing, packaging, and storage of their drug(s). Thus, the production and filing of DMFs has become an important aspect of regulatory compliance for pharmaceutical companies.
“Although it is not mandatory to submit DMFs to FDA, 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. Therefore, DMFs are still considered to be very important,” said the Marketing Chief of Proregulations.
Overall, the DMF preparation and filing process is complicated. The scientific team of Proregulations has abundant experience in dealing with such files and can help make sure that its clients’ DMF submissions are accurate, complete, and in compliance with relevant regulatory requirements. No matter it’s drug substances, excipients, and packaging materials that are to be submitted to regulatory agencies for approval, Proregulations is well-prepared to provide comprehensive support, and at the same time, guarantees expertise, timeliness, confidentiality of the whole project.
More specifically, Proregulations is capable of submitting the following types of DMFs to the FDA:
l APIs, intermediates, materials used in the preparation of the drug, or pharmaceutical preparations
l Packaging materials/containers
l Excipients, colorants, flavors, and essences
l FDA accepted reference information
About Proregulations
As an innovative and dynamic regulatory compliance solutions provider, Proregulations is capable of offering various tailored solutions that ensure compliance with various laws and regulations for its customers. By leveraging the expertise and industry knowledge of Proregulations' consultants, companies can streamline their products’ regulatory process and reduce time to market. To sum up, Proregulations can offer support in activities like FDA Medical Device Registration, 510(k) Premarket Notification, Drug Master File Document, FDA ANDA, FDA NDA, FDA Cosmetics Registration, New Dietary Ingredients Compliance, Toxic Substances Control Act Compliance, FDA Agent Services, Medical Device Distributor License, Market Authorization Application, Medical Device Establishment Registration, China Cosmetics Registration, EPA Pesticide Registration, etc.
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