I talked with a client who had problems with the quality of regulatory submissions. Her regulatory team members were making silly mistakes which ended up generating more questions from regulatory authorities and consequently delaying the approval timelines of submissions or occasionally getting rejection of their regulatory submissions. This was having a negative impact on the business overall.
She was getting really frustrated and started questioning the competency of her team members…
I asked the question during our call what systems you have given to your team with regard to peer review and quality checking of submission?
That question hit her deeply as she started thinking about the systems she has given to her team members.
She gave me a few examples but nothing robust enough to eradicate the silly mistakes which can be rectified by applying a good and simple system.
My Advice?
Simple…
“It’s never a personal problem. It’s always a systems problem.” the lesson I learnt from management guru, Peter Drucker:
In the same call, I gave her the idea of a quick and simple checklist and a proven peer review system which I used for my own team.
Without a solid regulatory system, you can waste hundreds of hours working on the wrong thing, then face disappointment and get burned out.
With the right systems, you can use a relatively small amount of effort and get extraordinary results.
By the end of the conversation, she was totally convinced and knew exactly what to do.
Six weeks later, she gave me feedback that by implementing this simple but powerful system, 95% of silly mistakes were gone; the business started getting quick results e.g. approval of even complex regulatory submissions without any RFI (request for further information), not even validation questions of new product submission, wasting less time and getting it right first time so you can focus on other important business things
Great….. results…
One conversation has taken all her stress away with regard to high-standard regulatory submissions and, more importantly, by avoiding blaming individuals, a healthy department environment was achieved, which resulted in other unquantified results.
Don’t implement the right regulatory solution to your problem and you’ll be chasing one tactic, gimmick and fad after another, hoping that the next one will save your regulatory department and create positive results.
As always, the choice is yours.
I am not promising that you will all have such a huge insight like what this client had during the call, which will take your all-regulatory worries away but I can promise you to provide advice and a space where you are more likely to have such insights to resolve your regulatory worries.
If you want to reduce your regulatory worries, book your call today!
Click here to book your call now
In this concise yet impactful call, we’ll:
🔍 Learn about your business and the regulatory challenge at hand.
🎯 Gain a crystal-clear view of your goals and identify potential regulatory hurdles.
🔧 Develop tailored regulatory solutions to tackle your most pressing challenges.
Best regards,
Aziz
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