CRED NPM

05/11/2024

Profile

The company needs to develop the product profile - defining what they want the product to be and how it will appear on the market

Strength of the product

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Indications

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Dosage

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Patient population

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Warnings

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Pack size

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The Organisation for Professionals in Regulatory Affairs

15

Resources

It is important to understand:

The potential resources and costs involved

The level of expertise and engagement required

Any potential limitations in timelines/budget

What the company wants from the reclassification

The Organisation for Professionals in Regulatory Affairs

16

8