A trial master file is a collection of important documents pertaining to a study, clinical trial or other form of research. Periodically, the trial master file must undergo audits to ensure the ...

This FDA compliance training will cover in detail the new requirements for trial master files including documents related to clinical trials that are required to be prepared, collected and maintained ...

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 ...

The guidance document discusses the preparation and submitting of drug master files as well as FDA’s review process. FDA announced the publication of draft guidance on drug master files on October 18, ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...