Performing a regulatory gap analysis:
How to maximize global opportunities from day one.
A guide to smarter regulatory planning.
From young ambitious biotechs to more established pharma brands, most life sciences organizations will at some point look to broaden their international reach as they identify new opportunities and/or reach saturation in their core markets.
Yet unless they have scoped the respective regulatory requirements for each new territory from the outset, and continue to track them over time, the process of preparing and applying for market authorisation in each additional country could be costly – threatening speed of access and profitability, certainly in the short term.
It’s in this context that it pays to perform an early regulatory gap analysis, identifying the additional or differing requirements of potential future markets – even if there are no immediate plans to take products into those additional countries.