PharmaBioServ, Inc
Facilitating the Revival of Drug Manufacturing in the US

The commissioner of the Food and Drug Administration (FDA), Stephen M. Hahn MD, communicated earlier this year that a manufacturer had alerted the FDA to a shortage of a drug that was recently added to the drug shortages list. FDA has identified many other drug companies that source their active pharmaceutical ingredients or finished drug products solely from Asia. In addition, they shared that 63 manufacturers that represent 72 facilities in China that produce essential medical devices were adversely affected by COVID-19.

A growing number of congress members, investors, and industry leaders recognize that efforts to diversify the supply chain are required to allow the US to be more in control of its citizens’ health, provide closer quality oversight, and increase reliability in the effectiveness of the drugs. Such action must truly be facilitated by the political and industry sectors, to ensure that the investment climate for “manufacturing at home” of pharmaceutical ingredients and finished pharmaceuticals, is attractive and competitive. The return of manufacturing back to US has shown to be a need to safeguard us all.

What would it take to create the turning point?

As a life sciences industry leader in regulatory compliance, validation, advanced therapy products, and other regulated industry support services, PharmaBioServ understands that to start the manufacturing of drugs in any place is not a short, simple process. It requires heavy investment in infrastructure, process development, technology transfer, validation, and regulatory agencies’ review and approval. “A fast track approach requires a well-thought strategy, transparency and collaboration to ensure quality is not jeopardized,” mentions Elizabeth Plaza, the president of PharmaBioServ. The company’s services are in accordance with the latest FDA, EMA, ANVISA, and other international agency regulations and guidelines. All PharmaBioServ’s services are founded on a philosophy of excellence through its personalized, hands-on experience and trained resources.

With over 27 years of experience, PharmaBioServ provides world-class global consulting services to the life sciences industry.

Bringing pharma manufacturing back would require tracing back to initial precursors and creating business opportunities to businesses willing to grow that niche, and PharmaBioServ can help to meet the regulatory requirements on a fast track approach, throughout the product life cycle

The company provides services to pharmaceutical, medical devices, consumer products, biotechnology, and advanced therapies products industries throughout the globe. “We have recognized the fact that we handed over our critical production to Asian countries for reasons we all acknowledge,” mentions Elizabeth. “Surrendering our production to Asia due to our patents expiring and looking for cheap production, we delivered knowledge, intellectual property and the resources to even render the place as a potential source of innovation.”

Bringing production back home will ensure taking control of some of the other challenges recognized before and during the pandemic. These include product quality and compliance to world regulations, logistics costs, and supply chain and speed of delivery. The FDA is working to increase foreign inspections and tackling its backlog of foreign facilities that have never been inspected. By the end of 2019, the FDA said it had finally inspected about half of those facilities and removed 37 percent of the companies on that list because they had gone out of business or were no longer serving the US market.

Still, some of the considerations that need further exploration and support include local incentives, environmental laws evaluation (especially APIs and reagents), manufacturing costs, and regulatory burden. Collaboration between regulators and industry, such as that demonstrated during this pandemic process, would enable a sustainable domestic manufacturing industry for API’s, pharmaceutical products, and medical devices. Bringing pharma manufacturing back would require tracing back to initial precursors and creating business opportunities to businesses willing to grow that niche.

Counting with the resources is key when considering reshoring. Plant Start Ups or expansions, Project Management to guarantee a technology transfer project on track and on budget, understanding the regulatory requirements, and ensuring a Validated State of Compliance, it’s what PharmaBioServ does. Count with us to ensure your manufacturing operations are in compliance here in US and around the world.