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Trusted Guidance

Montesino’s experienced team offers in-depth regulatory compliance and technical consulting in the realms of packaging and polymers, globally. After decades of hands-on experience, Montesino’s worldwide network of experts guides customers through highly regulated industries to achieve compliance, efficiency and sustainable business success.

REGULATORY

Montesino offers expertise and assistance in writing, editing, auditing and successfully submitting Type III Drug Master Files (DMFs), covering 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. Our proven track record with DMF submissions and audit programs along with our ability to serve customers across a wide range of needs and resources has positioned us as experts in this field.

DMF SUBMISSIONS

We offer a fixed project cost for helping to write, edit, organize and submit a DMF to the FDA with the goal of receiving a Type III DMF Number. This includes the formulation of templates for Letters of Authorization (LOA), amendments, and other documents needed to maintain the DMF once the DMF number has been obtained. We also correspond with the FDA regarding any questions or issues throughout the submission process, and provide ongoing assistance for annual updates and other amendments if so desired, functioning as an appointed DMF agent where needed.

DMF AUDITS

As a result of FDA updates over the past several years, there is now a greater focus within the agency upon packaging suppliers’ DMFs. Post-approval “interchangeability” guidelines specify that NDA (New Drug Application) 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 proven to issue multiple deficiencies to DMF holders for missing information, poor organization and a host of other issues. Subsequently, even 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 a significant negative impact on both the pharmaceutical company and supplier. Such a delayed product launch translates into an untimely roadblock and requires immediate action and resources to address the FDA’s concerns.

To decrease the risk of these delays, pharmaceutical companies can be proactive by involving a confidential third party to review suppliers’ DMFs and identify potential deficiencies before they become a problem. At Montesino, we perform DMF audits and maintain the confidentiality of their contents while working with the DMF holder to correct any deficiencies. These follow-up audits ensure issues are addressed in a timely manner, while status reports to pharmaceutical companies summarize findings without revealing details or violating any confidentiality agreements.

TECHNICAL

Montesino offers world-class technical service for pharmaceutical blister packaging. Our focus is aligned with our customers’ – deliver a package that assures the safety and efficacy of the product it protects. Our knowledgeable team of experts combines years of experience with materials and machinery to identify a range of solutions for blister packaging problems.

Here are some of the many technical challenges surrounding pharmaceutical blister packaging today:
  • Stability
  • Forming
  • Filling
  • Sealing
  • OEE

And some of the many factors that can further complicate these areas are: child resistant packaging, consolidating machines across various plants and operations, and changes in materials and/or suppliers, to name a few.

Serialization

In this environment of rapid change and ever-increasing demands for serialization and traceability, companies need timely regulatory information, especially in the global arena. Montesino’s serialization services offer a comprehensive understanding of emerging rules and regulations in this dynamic global sector, helping to solve the regulatory puzzle with innovative and customized solutions. We have a strong team of dedicated professionals with many years of industry and agency experience, and we provide the information needed to meet client needs in a timely manner.

Advising

As trusted advisers, Montesino works with clients to not only solve problems but to serve as a sounding board in developing new and broader perspectives. Defining problems before we can solve them, we identify issues and challenges in polymers and plastics, where change is constant.
 

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