REGULATORY APPROVALS
Just one missing.
Years ago, in MNC days, a 50 million USD commercial tender was just held ransom because of one device in the tender list.
Why? pending regulatory approval. It does not just mean this MNC didn't get the tender, but there's a very good reason the government is tending towards this MNC - clearly due to various favourable factors. And for one single regulatory approval getting stuck, to be disqualified from the tender, is a huge pity.
Years later, in a totally different environment, sometimes it is one single document that stunts the entire registration process.
it could be an insufficient clinical evaluation report, or missing cybersecurity tests, or even incorrect parameters for sterilization due to some incorrect assumptions. While the regulatory department would do their due diligence to read before submission, sometimes it's just too much and the time pressure forces the submission to just go through. Because, if something is really found to be missing, what can be done? Nothing, they think.
Really nothing? Is there no magic to get through somehow?
Firstly, it is to recognise that there are gaps. Denial is futile. Once they are found, then plans have to be made.
Secondly, is the "goalposts" - does it result in the indication for use being decreased? or a change in some of the declaration of functions/features?
Thirdly, is the team discussion of the first 2 points - to determine how much time is required to fix.
Some regulatory jurisdictions have either:
- limited review cycles (e.g China, Thailand)
- limited response time (e.g. Singapore)
It's never good to 'just submit' and see how it goes, because you may run out of Q&A, or run out of time.
Therefore, it's best to be found out as early as possible, consider the factors above, before proceeding together.
So, did the MNC get the 50 million USD tender? Yes, with difficulty (kind of)
and did the SME manage to resolve their missing document(s)? That would depend on how united and connected the various departments are to face the reality and do something about it.
Of course, if you are truly stuck, there's always us
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