Regulatory Officer

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Regulatory Officer Interview Questions and Answers

Updated 4 Feb 2024

Q1. How to prepare dossier

Ans.

Preparing a dossier involves gathering and organizing all necessary documents and information for regulatory submission.

  • Identify the specific requirements and guidelines for the dossier submission

  • Collect all relevant data, documents, and supporting evidence

  • Organize the information in a clear and logical manner

  • Ensure all required forms and templates are completed accurately

  • Review and verify the completeness and accuracy of the dossier

  • Submit the dossier to the appropriate regul...read more

Q2. Difference in CTD and ACTd

Ans.

CTD and ACTd are both regulatory submission formats used in the pharmaceutical industry.

  • CTD stands for Common Technical Document and is a standard format for submitting regulatory information for pharmaceutical products.

  • ACTd stands for Active Substance Master File (ASMF) CTD and is a specific type of CTD used for submitting information on active substances.

  • CTD includes sections such as Quality, Safety, and Efficacy, while ACTd focuses specifically on the active substance.

  • CTD ...read more

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