Product Dossier Registration Process
Product Dossier (CTD): Dossier is a collection of documents on the particular subjects. Any preparation of pharmaceutical product for human use go through the process of reviewing and assessing the…
Good Clinical Practices (GCP) Guideline
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. This guideline provides the procedure…
Quality Agreement Technical (Contract Manufacturing)
Quality Agreement means comprehensive written agreement that defines and establishes the obligations and responsibilities of the Quality Units of each of the parties involved in contract manufacturing of drugs subject…
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