Conducting business globally is an essential piece to many business strategies. However, we often see clients fail to realize the depth of planning required for geo-expansion of a product or brand. From getting the product registered and making on-pack claims, to meeting labeling standards – it’s all treacherous territory without a proper strategy.
We’ve seen businesses waste millions of dollars entering markets, only to discover a lack of appetite for the product. We’ve also seen businesses start down the geo-expansion path, only to make a U-turn, when they realize the complexity of international regulations.
To avoid making one of those all-too-common mistakes, here are four steps to consider before determining where in the world to sell your product.
1. Conduct a fast-cycle regulatory assessment for all countries of interest.
Conduct high-level regulatory assessments of all prospective markets. How is our product categorized and governed? Is there a submission / notification process? How long will it take to get approved? Can we launch without having a company registered in the market? Considering the regulations in each country will allow you to compare and contrast, set timelines and make decisions. While a certain market may be incredibly attractive, it might require significant reformulation, local clinical data and a lengthy submission process while others involve minimal adaptations and can bring in cash immediately to help fund your expansion. Considering these reviews holistically sets drastically different itineraries for market entry.
2. Do your own market research (beyond condition prevalence).
We often ask our clients why they’ve set their sights on particular foreign markets. Their answers are typically based on assumptions and rarely linked to higher-level strategy.
Even though patients are raving about your product in one region, does not mean they will rave about it in new regions. Figure out who your next target market is, then learn how they consume, where and why they buy, and then decide if you can deliver what they need to be successful.
Further to consider –will you need to lure customers away from a competitor? Competitor intel is pertinent in markets that are dominated by local players who have defined and owned customer expectations. How brand loyal are these customers? Are there differentiators to help you grab a share of the market?
3. Find local partners that make your life easier.
As development costs and regulatory pressures increase, the stakes for bringing a product to market have never been higher. Preparing a dossier is a challenging and tedious process that requires integrating all evidence to best represent the efficacy of your product, in a way that is compliant with regulations set by local (and likely new to you) health authorities. If you make one mistake, an already lengthy submission process becomes even longer. It’s important to find someone who understands the process and can manage each step until the product is registered.
Entering an international market almost always requires new packaging, formulation adaptation, claim reviews and new distribution partners. Establishing sourcing and manufacturing partners in a foreign land is tricky so it’s wise to have boots on the ground with local knowledge and resources that guarantee operations run as smoothly as possible.
4. Make a plan.
Once you understand the regulations, the consumers and the partners you’ll need to accomplish your goals, forge a plan. Create one to three-year agendas with expectations and assumptions. Outline which markets you’ll enter within each of those timetables and what it takes to get there. Consider which markets represent regulatory precedence so that you’re optimizing timelines and budgets.
Many of our clients want to penetrate a dozen or so markets, and it’s inevitable that some (if not most) markets will require you to reformulate. This also requires a plan. In most cases, it’s cost effective to spend due diligence dollars developing a few formulas that will work across all of the markets on your agenda, as opposed to making small tweaks for each.
Eliana D’Angelo – RegASK, Operations Manager
Eliana D’Angelo is a core member of the RegASK U.S. team, responsible for overseeing projects across multiple geographies. Eliana manages engagements designed to help clients navigate and provide clarity to the ever-changing regulatory environment. Prior to joining RegASK, Eliana played a central role in SPRIM’s communication practices, targeting both regulatory and medical professional communities. Eliana D’Angelo received her BS in Finance & Marketing from the University of Central Florida.