What do you do when you're the largest OTC brand in a major therapeutic area, but you're only marketed in the US? Call ISS.

In this case, a $1 billion brand was having difficulty breaking in to global markets due to differences in regulations and marketing approaches. ISS was called in to clear the path and outline a strategy for getting the products registered in Europe and other major markets around the world.

ISS didn’t stop there. We also crafted the strategy (including the approach for generating data, crafting the labeling, and writing the marketing authorization application) and conducted meetings with key regulatory agencies around the world, from China to the Netherlands, to ensure a harmonized approach with the greatest marketing flexibility and consistency.

Once the optimized strategy was in place, ISS was charged with strategic implementation and handled all elements of the execution, including oversight of product development, testing, and the development of a common technical document (CTD) that formed the basis of submissions, worldwide.

Extending the reach of the client's product beyond its traditional boundaries yielded incredible financial value and brand identity for years to come. Figuring out innovative, cost-effective approaches to getting products to market quickly is a key strength of the ISS team and the reason why our clients aren't bound by boundaries or borders.