7 steps to solve regulatory issues

Managing regulatory obstacles is a key essential factor in expediting the approval of the products. Yet it can be daunting when we receive pages long of questions.

Let’s look at the general workflow for solving regulatory issues.

  1. Categorize the questions into either administrative or technical. This will enable us to allocate our time better in solving the issues.
  2. Understand the question asked. Often, we find ourselves scratching our head at the “impossible” question being asked and assumption kicks in. What I recommend is to digest the question asked and highlight the points that I do not understand.
  3. Clarify any doubts. Speaking to the regulator via the phone is a clearer way of communication than email. With the points answered by the regulator, do follow up with an email to summarise and affirm the discussion points.
  4. Review what was submitted. When analyzing the question, it is good to see the relation between what has been submitted and the missing point that it fails to address. It can also help greatly with communication to the manufacturer that is supporting you.
  5. Work out possible solutions. When brainstorming solutions, it is good to make reference of step 1 to 4 so as to ensure that we address the objective of the question.
  6. Communicate to the manufacturer . When we send out queries to request for support, we need to be able to explain and supplement what is required from their end. Taking the extra effort to make someone’s job easier to help you will greatly increase the efficiency and time in response.
  7. Implement timeline to achieve the close out date. It is a good practice to have some leeway time to review the responses provided. A good yardstick will be to review any lacking response 1 week before the close out date/deadline.

By following the 7 steps above, it can increase your efficiency in dealing with pages long of queries and will enable you to foresee what’s going to come for the next round of queries. Good luck.

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