Pharmaceutical brand owners of all sizes are continuously looking for ways to reduce costs, manage liabilities, and maximize efficiency. For many, partnering with a contract development and manufacturing organization (CDMO) is proving to be a viable solution. Not only do CDMOs offer new product development capabilities, quality, and compliance, but they also have the capacity and capabilities to meet the needs of both small and large companies. And when unforeseeable macroeconomic challenges arise, having a CDMO in your target market could make all the difference when it comes to meeting customers’ needs and expectations.

Economic conditions can rapidly and drastically change, affecting the cost of raw materials, labor, and demand. For example, look at the shortages and fluctuating cost of oil because of the war in Ukraine, and the supply chain impacts that ripple when countries take unilateral actions to shutter key ingredient production facilities.

The COVID-19 pandemic created additional challenges especially when it comes to supply chains. The closures of borders, reduced international transportation, and trade restrictions impacted the movement of products globally. The pandemic also created workforce and regulatory challenges.

These unprecedented circumstances, as well as any disruption to the supply chain, can cause delays in production and impact the availability of pharmaceutical products. For those looking to meet an increased demand for products in the U.S., partnering with reliable CDMOs enables companies to better navigate through these challenges and come out on top.

Small brand owners in the pharmaceutical industry are looking for ways to avoid the capital costs, expenses, liabilities, and labor challenges associated with developing, manufacturing, and distributing their products. Partnering with a CDMO also gives them the ability to tap into specialized services and expertise. Meanwhile, larger companies are looking to reduce their manufacturing costs while increasing production capabilities, therefore closing sites, and focusing on growing their bigger brands and more efficiently producing their most in-demand products.

Choosing the right partner

As the demand for CDMOs in the U.S. continues to grow, choosing the right partner is becoming increasingly important. From capabilities and capacity to quality and compliance, selecting the right partner can have a significant impact on a company’s bottom line and its ability to meet customers’ needs and expectations. Here is what companies should look for when choosing a CDMO partner in their target market.

A good regulatory history is critical. As highly regulated as the pharmaceutical industry is, CDMOs must make compliance a priority. They must adhere to the same regulations and high standards as company-owned pharmaceutical sites and are responsible for ensuring that their products are compliant. In the U.S., the Food and Drug Administration (FDA) audits CDMOs often, making the results public if a violation is found. Do your research to ensure the CDMO you’re considering is in good standing. Working with a CDMO with a clean regulatory history provides the peace of mind and confidence that their products—meaning your products—are compliant and safe.

Your CDMO should have a good quality system in place. It should be able to show that it does the quality control and analytical testing required to guarantee the integrity and quality of its products. The CDMO should also be able to meet additional requirements set out by its customers, such as labeling and packaging. Having a good quality system in place also makes it easier and more efficient to onboard new customers.

Meeting broad capability requirements

The right CDMO will have the capabilities to manufacture a broad range of your existing product portfolio. A CDMO like Formulated Solutions, which recently acquired a new 455,000 square-foot FDA-approved facility, can manufacture one product into a variety of formats such as pharma-grade aerosols, BoV, nasal sprays, roller balls, liquids, creams, and more.

Consolidating your production portfolio to a handful of very capable production sites has many inherent benefits including minimizing complexity, reducing the amount of internal staffing required for oversight, as well as potential cost advantages. Identifying a production partner that supports a wide range of relevant product forms and dispensing formats is critical to achieving these goals.

When it comes to your capacity requirements, think about the future. Not only should your CDMO have the capacity to meet your current demand, but it must be able to meet an increased demand for your products over time. Make sure to choose a CDMO whose capacity can grow or has a vision to expand capacity as your business grows.

Your CDMO should have a proven record of developing new products that succeed in the market. A successful CDMO knows its customer’s portfolio and can offer compliance-focused product innovations, proactively and in line with the needs of the brand.

In support of the companies we call our partners, Formulated Solutions commits 30% of its research and development resources to speculative development. The product concepts that we create are specifically focused on helping grow the product portfolio of our most trusted partners. We do more than just blend and fill great products. We initiate new product development conversations and take our partners from conception to an entirely new, fully validated, lab-tested, and ready-to-distribute product.

As the pharmaceutical industry continues to expand and macroeconomic conditions impact nearly every part of it, CDMOs have become increasingly important. They provide a valuable service by helping to streamline the process of drug development, from production to testing and distribution. By investing in and partnering with domestic CDMOs, pharmaceutical companies can navigate and overcome many of the challenges the industry is facing now and in the future.

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Scott Carpenter is a 25-year veteran of the aerosol, CPG and consumer healthcare industries, having worked in leadership roles for several multinational corporations including SC Johnson, Merck and Bayer Consumer Care. As vice president of marketing and partner innovation at Formulated Solutions, a contract development and manufacturing organization (CDMO), Scott is responsible and has direct leadership of the innovation and development team. He is the proud recipient of more than a dozen U.S. patents for his work in creating new product and new package innovations. More info: FormulatedSolutions.com