About regulatory requirements

Dear expert,
Plz tell that if in interview it is asked that do you have knowledge about the regulatory work, then what does it actual mean.
What regulatory work cover itself.
What will we the correct answer.
Thanku in advance

As per my knowledge Regulatory Work means That work should done as per Standards,guidelines with specific cGMP
And if u are not following standard operating procedures, guidelines it was Non Regulatory.

It’s a extranal & intranal relationship between company and all regulatory authorities…
We need to understand and updated in our community to currently what regulatory requirements says everything about our products life cycle…

  • Following current versions usp, ep, jp… etc
  • DMF, CEP Submmitions.
  • Need to submit all parameters like development, process, analytical techniques,
    And also how to market it.