CDMO Solutions

Do you have the regulatory expertise to enter a new market?

CDMO Solutions

Do you have the regulatory expertise to enter a new market?

With its $500 billion pharmaceutical market, the US can be an attractive place for international companies to expand. Whereas American pharmaceutical companies typically look outside the US for growth opportunities when product categories become oversaturated, international companies can find opportunities to reach cultural niches within those categories.

For example, a Mexican supplement company with a line of immunity products might fare better at reaching the US Latino population than an American company with a similar line of products.

But breaking into any new market is fraught with challenges. Companies looking to enter the US market with an over-the-counter (OTC) product, for example, must comply with labelling laws enforced by the Food and Drug Administration (FDA) and advertising laws enforced by the Federal Trade Commission (FTC). Laws get even stricter when they involve prescription medicines.

These regulatory challenges aren’t unique to the US, however. Indeed, any company seeking to enter a new market must overcome regulatory hurdles it is rarely prepared to tackle on its own. In these cases, companies typically seek the services of a contract development and manufacturing organisation (CDMO) with expertise in the target market.

As Head of America for SFI Health Solutions, a full-service global CDMO, Matthew Brabazon has helped many multinational companies launch healthcare products in the US. In his experience, companies typically approach SFI Health Solutions with certain claims they would like to make on-label. SFI Health Solutions then works to determine the type and quantity of ingredients needed to make those claims based on US regulations, and formulates the product.

“A lot of times, we’ll discover additional label claims that can be made to further enhance the product and maximise sales opportunities.” – Matthew Brabazon, BU Head, SFI Health Solutions Americas.

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Case study: breaking in the US market

When a $750M multinational nutraceutical company wanted to launch a practitioner’s product into the US market, it sought guidance in two areas. First, it needed to reformulate the product to comply with US regulations. Next, it needed to learn how to position the new formula in an unfamiliar market.

SFI Health Solutions’ cross-functional teams rose to the occasion by delivering results in both areas. From a formulation standpoint, SFI Health Solutions’ medical research team read through academic journals and case studies to learn potency thresholds for the product category, allowing SFI Health Solutions to formulate a cost-efficient and effective product.

“When you look at any supplement in the US market, there’s a minimum threshold of input ingredients to legally state a claim against it,” explains Brabazon. “In this case, we researched the optimal product formulation to make the desired clinical claims while maximising the health benefit to the consumer.”

Around the same time, SFI Health Solutions provided regulatory guidance to the client’s marketing, product development and regulatory teams. This took the form of a three-hour workshop led by SFI Health Solutions’ science and education division. The workshop trained attendees on core ingredients and regulatory substantiation, ultimately allowing the company to develop an effective marketing and pricing strategy, including what to promote in social media posts, in-aisle displays, and digital ads to maximise sales.

“The guidance we can offer clients on formulation and claims allows them to design effective marketing collateral and know exactly what can and can’t be said from a regulatory perspective,” says Brabazon.

He adds that a workshop such as this is not a typical CDMO service, but SFI Health Solutions recognised a need, and was agile and knowledgeable enough to deliver.

“The more we can help our customers grow, the better it is for us and our customers,” says Brabazon. “So, if we’re able to use our resources to facilitate that growth, whatever that might entail, we will.”

In the end, SFI Health Solutions helped the client formulate and launch one of the highest potency products for the category in the US market. This, in turn, opened discussions with new retailers, further expanding sales opportunities. Based on the success of this project, SFI Health Solutions is now developing a new microbiome product for the client, which is scheduled to launch in 2022.

Who is SFI Health Solutions?

With world-class manufacturing facilities in the US, UK and Switzerland, SFI Health Solutions has long standing experience in the natural healthcare space. SFI Health Solutions can help any company, regardless of their size or location, design, develop and deliver natural healthcare products anywhere in the world.

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While SFI Health Solutions excels in conventional CDMO services, such as sourcing ingredients, developing products, labelling, and manufacturing, its global regulatory expertise is a huge differentiator and one of the main reasons why so many multinationals choose to work with them.

“Our in-house regulatory team is familiar with markets around the globe and can consult with clients to help them launch products anywhere in the world,” concludes Brabazon.

SFI Health Solutions’ global network means economies of scale and cost efficiencies. And, by handling all aspects of design and production in-house, customers get a single point of contact and complete transparency into costs, timeline and outcomes, helping to keep projects on-time and on-budget.

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