Health Canada is revising the Master File Application Form and merging it with the Master File Application Fee Form. This will streamline the application process and reduce the administrative burden ...

A collection of records pertaining to one of the main subjects of an information system, such as customers, employees, products and vendors. Master files contain descriptive data, such as name and ...

The SD File format offers benefits for KASA and cheminformatics to support regulatory submissions. Drug Master File (DMF) holders provide a hazard assessment for impurity classification to comply with ...

Derek Woodcock gives an overview of the Pharmacovigilance System Master File in our safety and pharmacovigilance themed month. The requirement for a Pharmacovigilance System Master File (PSMF) has ...