Pharma Consulting for challenging packaging requirements
Do you need regulatory support?
SCHOTT also supports regulatory inquiries, and have filed a number of Drug Master Files (DMF) for Primary Packaging Material with the US Food and Drug Administration (FDA), Health Canada and Chinese NMPA. These contain information about the Chemistry, Manufacturing and Controls (CMC) of our pharmaceutical packaging products.
To allow the appropriate authorities to review our DMF in support of customer drug applications SCHOTT will provide a Letter of Authorization (LOA) free of charge.