Raising the Bar in Packaging and Manufacturing

Clarke Solutions

To state the obvious, these are interesting days for pharmaceuticals. But that’s not stopping Clarke Solutions from helping the sector – along with companies in similar industries – flourish in demanding times.

Clarke Solutions is an Indiana-based company that creates products and offers services that improve operations and quality of manufacturing and packaging in several different industries. Pharmaceuticals and regulated industries are prominent on their customer list. The food and beverage industry too benefits from Clarke’s work. Companies that create medical devices also work with Clarke, as does the nutrition and supplement industry.

Opening its doors in 1999 as Clarke Engineering Services, the company was the brainchild of founder and owner Chris Clarke, bringing a fresh focus to engineering and validation services, mainly in packaging. Today, the company provides engineering, automation and validation services for FDA-regulated industries all over the United States.

Clarke president John Duffin says that Clarke outsources services that help its clients to effectively and efficiently launch, manufacture and package products safely and effectively.

“We help them with scale of operations, selecting the right manufacturing equipment, getting it installed and validated and maintaining it to keep it optimized and running effectively,” he says.

In 2007, Clarke Solutions created Acquire Automation, an independent firm also headquartered in Indiana. Acquire, too, offers products and services geared towards manufacturing packaging and technology.

Expanding expertise
Most recently, in the fall of 2019, Clarke acquired a Pennsylvania company called Covex, which also offers validation services, as well as management systems and compliance. Covex also offers enterprise IT compliance. The acquisition of Covex, Duffin says, was part of Clarke’s expansion strategy, and he is excited about Covex’s locale and what it means for business.

“Typically, our employees live in the Midwest, even though we do projects globally,” he says. “Covex is focused more in Philadelphia and the northeast, which is a hotbed for pharmaceutical and medical devices and the service offering is exciting as well.”

Duffin explains that Covex offered a convergence of IT (Information Technology) and OT (Operational Technology, which is the next step in technology systems: “IT systems that are managing quality and documentation, compliance and filings, at high levels; then there’s the OT, the devices, control systems, manufacturing, automation.

“The data has to flow up to meet compliance and compete in a world that is shifting from IT and OT being separated to a world that is ‘IOT’, where they’re converged,” he continues. He says acquiring Covex means Clarke Solutions will be on the leading edge – a firm that can bridge that gap from an engineering, automation and validation end-point.

“In other words, we’ll be the one company that can help our clients figure out how to do that effectively and work together effectively in areas that have been very much separated over the years. This is an exciting time for us.”

Doubling up
The acquisition of Covex doubled the size of the company, lifting $25 million of revenue to $50 million virtually overnight, as well as bringing employee numbers up to 300 in total. Duffin says Clarke is very focused on conception integration and value to clients, and on both organic growth and acquisitions to expand the company’s offerings to fit that IOT platform, as well as on the geography of acquisitions.

The move was welcomed by the Covex team as well. In a news release, Covex President Rich Tabarrini said his team shared the Clarke companies’ mission of trust: “As a single solution company, we now bridge the gap between information and operational technologies for enterprise companies that produce life-saving drugs and medical devices.

“With Covex’s strong, established relationship with larger pharmaceutical companies the combined organization provides connected, cohesive, compliant IT, manufacturing and software systems, plus our teams will expand the geographic reach of these synergized services in the regulated life sciences area.”

Further expansion, he says, will most likely include expanding into the southeast. “We already have some presence there, but we really want to expand that, maybe into the Research Triangle Park in North Carolina. But really, any geography where there is a lot of focus on pharma and devices and manufacturing technology – we want to continue to expand there and have a presence.”

Clarke Solutions has a vision of getting to $100 million in revenue over the next three years, doubling in size once again through organic growth and acquisitions. Duffin says company reps see this as making Clarke a leading player in its field. And all those acquisitions build the capability of offering the customer everything needed for a solution in any situation.

“It’s important to us to give the client the entire experience – and I know everyone says that, but it really is about customer service and the people around here,” says Duffin. “As you look in the space, there are a lot of providers that don’t have that infrastructure as business unit leaders or executive leaders that are engaged in the [area where] Clarke Solution is going to help you. That really is a differentiator for us.”

Top of a tough business
Duffin recognized that Clarke Solutions is in a competitive business. But none of his team is fazed by that.

“There’s a lot of interest in pharmaceuticals right now – and we’re private and equity backed at this point, having shifted from a bootstrap business to private-equity led – and I see more and more competition and more interest,” he says. “But we have a very value-niche-driven focus; we do offer something that is very hard to find.”

Pharmaceuticals is Clarke’s main business. Clarke strives to consistently improve the quality and operations it offers, and meet any company’s manufacturing and packing needs by delivering the right solutions at the right time.

Every company has various regulatory requirements it needs to follow, especially those manufacturing pharmaceuticals, and Clarke’s packaging and serialization solutions assure the safety and quality of every pharma product, at all times.

Clarke shines in the medical device area as well. Specialists under the company umbrella offer a unique skillset, helping clients meet any specific deadline, which in this day and age is critical. These specialists are members of dedicated teams focusing on product testing long before pre-release, or even pre-approval, stages.

Nutrition is one of the most important aspects of health and well-being, and Clarke is leading the way in preparing for the anticipated industry-wide FDA regulations. Validation processes are being greatly improved by Clarke specialists, meaning nutrition supplements will be made safer for consumption for years to come.

Social media and success
Social media is a force to be reckoned with in the new reality of the 21st century. Recalls are bad business for any company, especially one that manufactures food and beverage products.

Clarke helps with product validation and ensuring that packaging adheres to any and all regulations. In fact, any company making products or providing services in any regulated industry can rest assured that Clarke Solutions has the experience, technology and people to help it stay competitive and fully operational.

Last year marked 20 years in business for Clarke Solutions. Duffin says that over the years, both management and employees have amassed the kind of know-how that only time and experience can bring.

Trust, trust and trust
“As we evolved, we’ve really come to learn who we are, where we sit and where our expertise lies,” he says. “As we grow to the point where we know what we do well, we’ll stay focused in those areas.”

It’s all about trust, he explains: “[Our clients] are developing and launching life-saving drugs and we’re a key part of making sure those are compliant products that are safe and effective,” he says, “and the rest doesn’t matter.

“We develop that trust by knowing who we are and delivering each and every time in the areas where we have that expertise-set.”

Legally, Clarke Solutions can’t reveal its clients. But Duffin says that 90 percent of its business comes from pharma companies, all of whom have a massive challenge on their hands with the Covid-19 pandemic reaching around the world. He says it could be close to a year before a vaccine is created although even then, it needs to be approved by the FDA, scaled up and manufactured.

But we’ll still get through it better because of the massive enabling capabilities that Clarke Solutions puts at the service of these pharma companies, and many others.