No pharmaceutical company wants to receive a deficiency letter. These cease and desist-style letters from regulators notify pharmaceutical companies of deficiencies in their products or production process, requiring a quick resolution to be able to market the over-the-counter (OTC) supplements to the public.

Deficiency letters usually contain minor or major issues – or deficiencies – with a product. Deficiency letters typically involve safety, efficacy, or manufacturing, and include a description of deficiencies, along with possible resolutions.

According to Chemical & Engineering News, the repercussions of receiving such a letter can include delayed approval, lost business, and financial uncertainty. In addition, stockholders and investors may react negatively, causing a company’s valuation to fall, or limiting its ability to raise capital. Company reputations can suffer, and much-needed supplements may be unavailable.

When asked about the prevalence of these letters, Christian Von Dach, Head of EMEA at SFI Health Solutions, says they’re issued quite often.

“The problem is common worldwide,” notes Von Dach. “Once you receive a deficiency letter, you’ll have three to 12 months on average to fix the problem, and resolving deficiencies takes time. Therefore lifecycle management of the product is crucial to make sure the formulation is compliant. It is fundamental to proactively anticipate the requirement of new regulations and make changes to the formulation before it even gets to the stage of a deficiency letter getting issued.”

Another complicated matter is the fact that regulations vary by country, so an excipient (such as a colouring agent, preservative, and filler) that’s legal in Mexico might not be in Canada. This adds complexity for companies that manufacture supplements in one country and distribute them worldwide.

“The clock starts ticking as soon as you receive the letter,” notes Von Dach. “So, unless companies have their own in-house manufacturing capabilities, they’ll have to refer to a CDMO they trust to resolve the deficiency within the given timeframe.”

Turning potential revenue loss into financial gain

SFI Health Solutions is a global contract development manufacturing organisation (CDMO), specialising in OTC supplement formulations. So, when a Swiss pharmaceutical company received a deficiency letter for one of its therapeutic active ingredients – present in an established product in Switzerland – it turned to SFI Health Solutions for help.

According to the information received from the authority, the product’s active ingredient no longer complied with Swiss regulations. As such, the client urgently needed a new formula. Without it, the company risked losing reference for the product and therefore an estimated 10% of annual revenue.

After analysing the new regulations, SFI Health Solutions’ product development team reformulated the product to resolve the deficiency. The formula upgrade not only corrected the active ingredient issue, but also included adding state-of-the-art excipients to improve the product’s quality.

In addition, SFI Health Solutions helped the client develop a strategic regulatory plan for maintaining the registration of the product as an over-the-counter (OTC) in the Swiss market. After the client approved the new go-to-market strategy, SFI Health Solutions’ cross-departmental team– including R&D, drug regulatory affairs, and project management – worked alongside the client to implement the plan, concluding with the successful submission of the dossier to the health authorities.

In the end, it was SFI Health Solutions’ end-to-end capability that helped the client maintain the product’s OTC status in the Swiss market. The new formula not only prevented the loss of revenue, but it also helped the client grow sales by 10% and improve its reputation and credibility in Switzerland.

When reflecting on this experience, Von Dach explains how pharmaceutical companies can avoid dealing with the stress of deficiency letters by performing routine maintenance on their products, and crucial to this is partnering with an experienced CDMO with deep regulatory knowledge.

“Consider reformulating your products to keep up with the latest science,” Von Dach explains. “After reformulating this client’s therapeutic product, we helped them reformulate three additional products before deficiencies were identified, saving them time and money.”

Deep knowledge, economies of scale

When it comes to reformulating products – or contract manufacturing in general – not all contract development manufacturing companies (CDMOs) are created equal. So, for companies that outsource production, the last thing they want to hear is that their CDMOs are non-compliant in regards to Good Manufacturing Practices (GMPs).

SFI Health Solutions fully complies with GMPs. The company maintains strong connections with regulators worldwide, giving it a unique insight into regulatory matters to help clients market their products worldwide to follow country-specific regulations.

“This is a surplus compared to our competitors,” notes Von Dach. “Not a lot of companies have our development knowledge or worldwide connections.”

Photo: SFI Health Solutions’ production facility in Bioggio, Switzerland.

SFI Health Solutions’ global network brings economies of scale. And, by handling all aspects of production in-house – including reformulating products, sourcing ingredients, product design, product development, and labelling – customers get a single point of contact and complete transparency regarding costs, timelines and outcomes, keeping products on time and on budget.

Visit sfihealthsolutions.com to learn more.