Business View Magazine | March 2020

48 BUSINESS VIEW MAGAZINE MARCH 2020 to sell that product, because, throughout the world, there are different regulatory agencies that govern the manufacture of pharmaceutical products. In the U.S. that’s the FDA; overseas there is the EU Commission; and the World Health Organization (WHO) for most of the world. “Understanding how those regulations apply to biotechnology, cell and gene therapy, oral solid dosages, creams and ointments, and medical devices, is key. There is such a broad range of regulations that we have expertise in each of those manufacturing units that can help a customer navigate the complexity of the regulatory process. Once we define which regulatory agencies are going to impact the facility design and operations, we can start to design their process, and create the manufacturing flow diagrams and the process instrumentation diagrams. Then, we start the facility design and look at the efficiencies and space optimization for process equipment. Ultimately, we take those design drawings out and bid the contractors to obtain the best price, the best value, to build the facility. “And our team validates that, which is an FDA requirement, to prove the facility is not going to have any impact on the efficacy of the drug being manufactured. Essentially, by following this process of understanding the products they want to make, understanding how they are manufactured, and then putting a facility around it, we stay very close to our customers’ goals. We do that for the branded pharmaceutical companies, for the contract manufacturers – it’s a broad mix of clientele.” President & Managing Director, Mark Butler