Montesino offers expertise and assistance in writing, editing, auditing and successfully submitting Type III DMFs. This covers a wide range of packaging materials such as resins, blister films, blister foils, bottles, closures, closure liners, glass, rubber, flexible packaging, cotton and molded components.
Montesino takes pride in its successful track record of DMF submissions and DMF audit programs, as well as our flexibility in working with customers with varying needs and resources. Please feel free to contact us so that we can discuss your requirements in more detail or if you have any questions whatsoever.
Montesino normally quotes a fixed project cost for helping to write, edit, organize and submit a DMF to FDA, with the final goal of receiving a Type III DMF No. This includes the formulation of templates for Letters of Authorization (LOA), amendments, and other documents which will be needed in the routine maintenance of the DMF once the DMF No. has been obtained, as well as corresponding with the FDA should there be questions or any issues during the submission process. Montesino can provide ongoing assistance for annual updates and other amendments if so desired. Montesino can also function as an appointed DMF agent where needed.
As a result of FDA guidances over several years there is now a greater focus than ever within the agency upon packaging suppliers’ Drug Master Files. Post Approval Changes “Interchangeability” guidelines mean that NDA reviewers are now essentially approving packaging materials for all future applications, as opposed to solely for use with the specific drug under review. Under this heightened scrutiny, reviewers have demonstrated a willingness to issue multiple deficiencies to DMF holders for missing information, poor organization and a host of other issues. Suppliers who have maintained DMFs with little or no change for years are now receiving deficiency letters.
An NDA approval which is delayed due to supplier DMF issues has significant negative impact to both the pharmaceutical company and the supplier. Such a delayed product launch translates to an untimely roadblock and requires immediate action and resources to address FDA’s concerns.
Pharmaceutical companies can be proactive in this process to lower the risk of delayed NDAs due to inadequate DMFs. A confidential 3rd party review of suppliers’ DMFs can help avoid potential deficiencies now, before they become a problem. Montesino Associates can perform DMF audits and maintain the confidentiality of their contents while at the same time work with the DMF Holder to correct major and minor deficiencies. Follow-up audits help ensure that issues are indeed addressed in a timely manner. Status reports to pharmaceutical companies can summarize findings but not reveal details nor violate Confidentiality Agreements.