Who is asking the question about Regulatory Strategy and what is the ultimate ask (i.e. what info are they really looking for)?
1. Is it the VP of Marketing/Sales looking for the quickest route to a cleared product (e.g. US - 3 months for a 510(k) vs. Canada - 15 days for an MDL vs. China - a really long time)?
2. Is it the VP of Product Development looking to understand the technical documentation requirements (think: what is the least amount of work we need to do in terms of defining requirements, testing product, etc. to get product to market)?
3. Is it the VP of Regulatory looking to plan out the regulatory and QMS work for the next year? The suggestions in this thread are great.
It boils down to this: Who will spend money on your product and where are they located? A SWOT analysis from a regulatory perspective would determine which markets to prioritize.
Oh and thanks for shout out
@Glen Park! It IS a great chapter :D
@Robert Falcone and I worked hard on it.
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Karen Fan MSc RAC PEng
Manager, Regulatory Affairs and Quality Assurance
Rostrum Medical Innovations Inc.
Canada
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Original Message:
Sent: 30-Jan-2020 08:13
From: Glen Park
Subject: Regulatory Strategy Question
Although I agree with Richard about the vagueness of the question,a good place to start would be Capter 10 of the Fundamentals of US Regulatory Affairs by Karen Fan and Robert Falcone. They cite the FDA guidance on Target Product Profile and their Table 10.3 has an excellent list of questions to ask in developing a strategy.
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Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States
Original Message:
Sent: 29-Jan-2020 15:30
From: Karen Zhou
Subject: Regulatory Strategy Question
Hello everyone,
I'm seeking some advice on putting together a regulatory strategy. What are some questions I should be looking for? If anyone has any guidelines on putting together a regulatory strategy, I'd appreciate it.
Thanks very much.
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Karen Zhou
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