What is difference between Form 483 and Establishment Investigation Report ?
Form 483 and an Establishment Investigation Report (EIR) are both documents used by regulatory authorities, particularly the U.S. Food and Drug Administration... Read More
What is Design of experiments (DoE) approach?
Posted on21 Feb 2024
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Design of experiments (DoE) is a systematic approach aiming to maximize information content from an experimental study, while keeping the number of... Read More
What is Quality by Design (QbD)?
The pharmaceutical Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process... Read More
Indication splitting in biopharma licensing
While licensing in bio pharmaceutical business, if licenses are issued to different partners based on indications or disease and therapy, then this... Read More
What are the difference between regulatory affairs and pharmacovigilance working?
Posted on21 Feb 2024
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Pharmacovigilance professionals deals with the adverse effects, and regulatory professionals work on registration and regulation of drug. Pharmacovigilance professionals are focused on... Read More