Romark: Heading the New Wave of Puerto Rican Pharma Manufacturing

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Headquartered in Tampa, Florida, Romark focuses on developing innovative treatments for infectious diseases and the latest newcomer to Puerto Rico. CEO Marc Ayers recounts how he came to the decision to establish the company’s first manufacturing plant of finished products on the US territory.

 

What ultimately made the difference was the calibre of the talent and the quality of the infrastructure available [in Puerto Rico] in pharmaceutical manufacturing

Marc Ayers, Romark

“We were at a point in the development of our company where we needed to be able to control the pharmaceutical manufacturing process,” he states. “We were looking for opportunities to be able to manufacture large quantities of products, and ideally to be able to do it ourselves. A friend explained the incredible economic development package being offered by PRIDCO to a Spanish company that was considering establishing operations on the island.

 

“However, what ultimately made the difference was the calibre of the talent and the quality of the infrastructure available here in pharmaceutical manufacturing,” continues Ayers. “Florida cannot yet compare to Boston, New Jersey, and the San Francisco Bay Area in pharmaceutical manufacturing and, as a result, it is difficult to find and attract talent. When we came to Puerto Rico, we were able to meet industry leaders and veterans interested in building something special together.”

 

“Establishing our manufacturing facility here helps us ensure business continuity, mitigate risks, and reduce costs. In addition to our manufacturing facility, we also acquired an analytical laboratory in Dorado. Together with our API facility in Belgium, we have the ability as a vertically integrated pharmaceutical company to develop new products and bring them to market,” he proclaims.

 

For the project, four local firms, each one an expert in its area, teamed up to provide a turnkey solution: Design (CMA), Engineering and Mechanical (BLDM), General Contractor (CIC Construction Group) and Project Management, Commissioning and Validation (Pharma-Bio Serv). Together, they designed, built and validated the new facility with Quality by Design as the end goal. “As the project moved along, the required documentation was developed to meet the FDA’s requirements. By integrating the validation process since day one, we were able to reduce time-to-market by about a year,” emphasizes Francisco Díaz-Massó of BLDM.

 

“This project was centred around listening to the needs of the client. Based on that, we were able to develop the best strategy to reach the objectives in a timely manner,” adds Jorge Tirado, Managing Partner of CMA. “This is an unparalleled innovative approach to Technology Transfer, applying local knowledge with an integrated team of specialized firms to increase efficiencies and Quality,” stresses Elizabeth Plaza, founder & chairwoman of Pharma-Bio Serv.

 

Ayers invites other companies to follow Romark’s lead and establish manufacturing facilities in Puerto Rico. “Puerto Rico is an island of opportunity for companies seeking to mature to the product commercialization stage because talent is readily available,” he states. “People are highly educated, have unmatched experience in the industry and there is a quality-driven culture.”

 

Elizabeth Plaza agrees: “Big pharma companies are consolidating and finding themselves with excess capacity. Although they still play a very important role in the Puerto Rican manufacturing landscape, we see great opportunities for small and medium-sized companies to come here and take advantage of the experience that multinationals have built.”

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