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Gamma Sterilization

By Janet Gaboury, PhD

十月 21, 2019

West Regulatory Affairs (RA) has a goal of harmonizing site-specific Drug Master Files (DMFs) into a global document as the processes at different facilities are synchronized.

A Compass with the needle pointing North to Leadership

By Stephen LoCastro

五月 18, 2017

Both the FDA and Health Canada have issued guidances to industry that require Drug Master Files (DMFs) to be provided in electronic formats by defined deadlines.