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.
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.
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.