Senior Regulatory Affairs Officer Interview Questions and Answers

The permissible limit of biotin in India is not available.

• The specific limit of biotin allowed in India is not mentioned in any regulatory documents.

• The Food Safety and Standards Authority of India (FSSAI) does not provide a specific limit for biotin in its regulations.

• The use of biotin as a dietary supplement is generally considered safe, but specific limits may vary depending on the product and its intended use.

• It is advisable to consult the relevant regulatory authorities ...read more

Dossier guidelines are regulatory requirements for the submission of drug or medical device applications.

• Dossier guidelines vary by country and region

• They outline the necessary information and format for the application

• They may include requirements for clinical trial data, manufacturing information, and labeling

• Examples of dossier guidelines include the Common Technical Document (CTD) and the Electronic Common Technical Document (eCTD)