Module 1 2021

28/06/2021

Regulatory strategy for SMEs

Regulatory awareness • Often low for SMEs and virtual companies • However, need to be high especially for: • L ean and mean dev. strategy • Changing strategy • Soft skills

The Organisation for Professionals in Regulatory Affairs

15

Take-home message SME

• SME regulatory and data requirements are the same • SME status facilitates process and increases chance to success • Regulatory strategy in SME often financially driven whereas time-driven for Big Pharma • Challenge - align regulatory strategy with business goals

The Organisation for Professionals in Regulatory Affairs

16

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