Disruption to Delivery: How to Ease the Burdens While Raising the Quality Assurance Expectations

For Metis Consulting Services

By Michael Bronfman

September 8, 2025

Welcome to this week at the Guard Rail! Global events are constantly challenging the supply chain in our industry, the pharmaceutical space faces a unique tightrope walk. At Metis, we understand the dual pressures of getting vital therapies to patients quickly while ensuring every single product meets the highest safety standards. This article dives into how companies can find the sweet spot, protecting both public health and their business without overwhelming their teams.

The pharmaceutical industry stands at a complex crossroads. Companies face constant pressure to deliver new therapies faster while meeting strict safety standards. At the same time, global supply chains remain vulnerable to disruption, and regulatory agencies continue to raise expectations for quality assurance.

These trends create a heavy burden for manufacturers, distributors, and quality teams. The challenge is to ease that burden without lowering the standards that protect patients.

This article will explore the causes of delivery disruptions in the pharmaceutical sector, the growing expectations for quality assurance, and the strategies that companies can adopt to balance both sides. The goal is to show how organizations can protect patient access to medicine while ensuring that every product meets the highest possible quality standards.

The Nature of Delivery Disruption

Delivery disruption can take many forms. Global events, such as pandemics, have shown how quickly supply chains can break down. Political conflicts and trade restrictions also place limits on the movement of raw materials. Even natural disasters, such as floods or earthquakes, can create sudden shortages.

Disruption can also arise from within the industry itself. Complex manufacturing processes can lead to delays when equipment breaks down or when staff shortages occur. Quality concerns that require additional testing may slow down production lines. If regulators identify concerns during inspections, companies may need to halt shipments until corrective actions are complete.

In the pharmaceutical space, these disruptions carry higher stakes than in most industries. Patients rely on timely access to treatments. Delays in delivery can worsen disease outcomes or reduce trust in the health care system. For companies, disruption leads not only to lost revenue but also to reputational damage that can last for years.

Rising Expectations for Quality Assurance

While supply chain risks grow, regulators and patients expect higher levels of safety and reliability. Quality assurance is no longer seen as a supporting function but as a central pillar of the pharmaceutical business. Agencies around the world demand more rigorous documentation, more transparent data, and stronger monitoring across the product life cycle.

Quality assurance today extends far beyond the factory floor. It includes supplier audits, shipping controls, temperature monitoring, serialization, and post-market surveillance. A single misstep at any point can trigger recalls, fines, or loss of license.

The paradox is clear. Companies must deliver faster and more reliably, while also meeting more demanding quality requirements. The result is pressure on staff, systems, and budgets. This is why new approaches are necessary to ease the burdens without lowering the bar.

The Burden on Organizations

When disruption meets higher quality expectations, the result is strain across the enterprise. Manufacturing staff must work longer hours to keep up with delays. Quality professionals must review more data and more reports than ever before. Regulatory affairs teams must stay updated with complex, often changing rules across many countries.

The burden extends to suppliers as well. Raw material providers must show compliance with strict guidelines. Distributors must track conditions during shipping. Even pharmacies and hospitals must store products according to strict requirements, which can be difficult in resource limited settings.

Financial pressure adds to this burden. Every additional quality measure costs money. Extra testing, additional audits, or investment in monitoring technology all increase expenses. Companies must balance these costs against the pressure to make medicines affordable.

Easing the Burdens without Lowering Standards

The question for industry leaders is how to reduce stress on staff and systems while still meeting the rising expectations. Several approaches can help.

1. Building Resilient Supply Chains

Resilience begins with diversity. Companies should avoid relying on a single supplier or a single geographic region for key ingredients. Multiple qualified suppliers can reduce the risk of shortages. Local or regional sourcing, where possible, can reduce exposure to global shipping delays.

Resilience also requires stronger collaboration. Sharing information with suppliers, distributors, and regulators can prevent small issues from turning into major disruptions. Transparency about challenges builds trust and allows all parties to prepare together.

2. Investing in Workforce Development

Staff members remain the most important resource for quality assurance. Companies must invest in training programs that build both technical skills and problem-solving skills. A workforce that understands quality requirements can catch errors early, reducing delays later.

Support for employee well-being also matters. Long hours and constant pressure lead to fatigue, which in turn can create mistakes. Providing balanced schedules, clear communication, and mental health resources helps staff remain engaged and careful.

3. Streamlining Processes

Many burdens arise from complex and outdated processes. Streamlining workflows can remove unnecessary steps while keeping compliance intact. Clear documentation, standardized procedures, and better alignment between departments reduce duplication and confusion.

Process mapping can reveal where bottlenecks occur. Once identified, leaders can simplify approval chains or adjust schedules to prevent repeated delays. Streamlining does not mean cutting corners. It means working smarter to reach the same quality outcomes with less wasted effort.

4. Enhancing Monitoring and Transparency

Disruptions are easier to manage when detected early. Strong monitoring of supply chains, production lines, and shipping conditions provides early warning signs. With timely data, companies can respond before issues escalate.

Transparency is the key. By sharing monitoring data openly, companies show accountability. This can reduce the number of surprise inspections and create a more cooperative and trustworthy relationship with oversight agencies.

5. Encouraging Cross-Functional Collaboration

Quality assurance does not belong to one department. Manufacturing, supply chain, regulatory affairs, and commercial teams all play a role. Cross-functional collaboration ensures that quality standards are considered at every stage.

When departments work together, they can share resources, identify risks earlier, and support one another during disruptions. This culture of shared responsibility lightens the load on any single group while raising the overall standard.

The Role of Technology

Although new tools can feel like an added expense, they often reduce the burden in the long run. Digital monitoring systems can track temperature and humidity during shipping with greater accuracy than manual methods. Cloud-based platforms allow global teams to share documents in real time, reducing the delays caused by communication gaps.

Automation in manufacturing can improve consistency, reduce errors, and free staff from repetitive tasks. Predictive analytics can help forecast supply needs, reducing the risk of sudden shortages. These technologies do not replace the need for human oversight but rather support staff in meeting higher expectations more efficiently.

Case Study: Managing a Major Disruption

To illustrate the balance between easing burdens and maintaining quality, consider a company that relies on a single supplier for a critical raw material. When political conflict disrupts trade, the supplier can no longer ship the material. Production halts, and patients face the risk of delays in receiving treatment.

A company that has built resilience would have pre-qualified a second supplier in another region. Quality assurance teams would already have reviewed the supplier’s processes, ensuring compliance with all standards. With this preparation, the company can switch suppliers quickly, avoiding a major disruption.

At the same time, the company maintains transparent communication with regulators and health care providers. By explaining the switch, sharing data about supplier compliance, and monitoring product performance closely, the company both eases the burden of crisis management and raises the standard of accountability.

Preparing for the Future

The pressure on pharmaceutical companies will not decrease. Global events will continue to disrupt supply chains, and regulators will continue to raise expectations. The companies that succeed will be those that prepare now.

Future readiness requires long-term planning. Leaders must see beyond immediate cost savings and recognize the value of resilience and quality. The investment made today in training, monitoring, and supplier diversity will pay off when the next disruption arrives.

It also requires a cultural shift. Quality must be seen not as a cost but as a value. It protects patients, strengthens reputations, and builds trust. By making quality a shared responsibility across the organization, companies can meet higher expectations with less individual strain.

Disruption to delivery is inevitable in the modern pharmaceutical landscape. Rising expectations for quality assurance make the challenge even greater. Yet companies need not choose between burden and safety. Through resilient supply chains, workforce investment, streamlined processes, enhanced monitoring, collaboration, and thoughtful use of technology, it is possible to ease the load while raising standards.

The future of pharmaceutical delivery depends on this balance. Patients deserve both timely access and reliable quality. Companies that find ways to reduce the burdens while maintaining strict assurance will protect both public health and their own long-term success.

The pharmaceutical industry will continue to face disruptions and rising expectations. The time to prepare is now. Don't let the dual pressures of delivery and quality assurance compromise your mission or strain your team. At Metis, we will collaborate with you to build the resilient systems and streamlined processes necessary to thrive in this complex environment. Let's start a conversation about how we can help you turn disruption into an opportunity for excellence. Reach out to us at hello@metisconsultingservices.com and take the first step toward a more resilient future.

The Advantages of Bringing Pharmaceutical CMOs Back to the United States

For Metis Consulting Services, Inc. 

By Michael Bronfman

August 11, 2025

This week in the "Guard Rail," we at Metis are exploring "Reshoring" of CMOs. We can't afford to settle for anything less than a fortified, domestic, and regional pharmaceutical industry. For decades, the lure of international manufacturing offered a path of lower costs, but this road has proven to be full of potholes.

The Benefits of Bringing Pharmaceutical CMOs Back to the United States (Reshoring)

The pharmaceutical industry plays a central and critical role in public health. Every stage in the drug development and manufacturing process impacts the final quality and safety of medicines. Contract Manufacturing Organizations, known as CMOs, are third-party organizations that manufacture drugs for pharmaceutical firms. These organizations handle activities ranging from producing active pharmaceutical ingredients (API) to packaging and labeling.

Over the past several decades, a large number of pharmaceutical manufacturers have moved overseas. Let's talk about why this is happening: cost savings, reduced labor expenses, and relaxed regulatory environments often tempt companies to China and India.

There have been growing discussions lately about the benefits of bringing pharmaceutical CMOs back to the United States. The term for this movement is "reshoring." The trend to shift overseas has come with a set of challenges and risks that directly impact quality, safety, and national security. Although reshoring requires investment of all kinds, including time and workforce development, among others, it also brings a wide range of returns on those investments. These advantages include improved supply chain resilience, increased product quality, strengthened national security, job creation, and a reduction in reliance on foreign manufacturing. And isn't that what we all want?

Here, we will take a bigger look at how reshoring CMOs to the United States offers long-term benefits to both the pharmaceutical industry and the public.

Improved Supply Chain Reliability

Pharmaceutical manufacturing operates most effectively with a stable supply chain. Delays, shortages, and disruptions have serious consequences for patients' access to the drugs they need. The complexity of global supply chains is in itself a challenge that creates multiple points of vulnerability. Drugs may pass through several countries before reaching their final destination. Disruption along this path, at any point, can lead to delays or stockouts. The long, complex chain is vulnerable to myriad forms of delay, including political tensions, natural disasters, or transportation failures.

By relocating CMOs to the United States, pharmaceutical companies can reduce the number of steps involved in the supply chains. As a result, we would expect faster delivery of finished products and improved response times during public health emergencies. A domestic manufacturing base allows for greater control over production scheduling and inventory management.

During the COVID-19 pandemic, global supply chain disruptions exposed the risks of overdependence on foreign manufacturing. Not just for us here in the US, but globally. Shortages of essential medications and active pharmaceutical ingredients were rampant. A more localized supply chain could help prevent similar problems in the future.

Enhanced Quality Control and Regulatory Oversight

The United States Food and Drug Administration enforces strict regulatory standards. The manufacturers must follow detailed guidelines to ensure safety, consistency, and efficacy. When pharmaceutical companies outsource production to overseas CMOs, consistent quality and quality oversight are more challenging. Regulatory agencies often lack the same reach and oversight capabilities in other countries.

If their CMOs are located back here in the United States, companies gain better access to real-time oversight, audits, inspections, and monitoring. Regulatory compliance is easier to enforce, and deviations from quality standards can be addressed more quickly. This results in fewer product recalls, improved batch consistency, and greater confidence in the quality of the medication supply.

Patients should always be the guiding light in pharmaceutical manufacturing. They deserve safe and effective treatments. A return to domestic production would enhance quality assurance. Improving it every step of the way, from raw material sourcing to final packaging.

Stronger National Security

Pharmaceutical products are a cornerstone of national health and security. When production is concentrated overseas, vulnerabilities become more apparent. Whether it is interruptions to supply or trade restrictions, or foreign political instability, we have more challenges to the health and security. In times of crisis, foreign governments may prioritize domestic needs and restrict exports of critical medications.

Now let's look at that risk when considering essential medications such as antibiotics, vaccines, and insulin. The lack of domestic manufacturing capacity limits the nation's ability to respond to emergencies. If there is another pandemic, or there are bioterrorism threats, or a natural disaster, reshoring pharmaceutical CMOs will strengthen national security by reducing dependence on international suppliers. This will allow for faster production of essential drugs in response to urgent needs. We need to mitigate the vulnerability before any of these disasters strike. With a domestic manufacturing infrastructure in place, as a result, the United States, or even the Americas, will be able to better protect its citizens during emergencies and avoid the harmful effects of drug shortages.

Economic Growth and Job Creation

Potential for economic development is another major advantage of bringing CMOs back to the United States. The pharmaceutical industry is a sector that is growing and expanding. This vital industry can provide high-paying jobs in science, engineering, quality control, and logistics.

Local communities are economically stimulated in related industries, including transportation, utilities, and construction. Building new manufacturing facilities or expanding existing ones could create employment opportunities for both skilled and entry-level workers. As more companies invest in domestic production, entire ecosystems develop around pharmaceutical hubs. These ecosystems create long-term economic benefits that go beyond the companies themselves.

In regions facing economic decline, pharmaceutical manufacturing plants have the potential to provide a much-needed economic boost. The jobs that are created tend to have better wages and benefits than many other industries, contributing to a higher standard of living. This, in turn, creates community stability.

Increased Transparency and Accountability

Patients, providers, and regulators must know where medications are produced and under what conditions. Transparency is essential. When production is moved overseas, transparency often decreases.

Domestic manufacturing encourages greater openness. Regulatory agencies have greater ease of access to inspect facilities and review records. Companies can communicate more clearly with the public about sourcing, safety, and compliance. This builds trust between the pharmaceutical industry and the patients it serves.

Consumers are showing interest in where their medications are made. Just as people care about the origin of their food, many want to know whether their medicines are produced safely and ethically. Reshoring supports this desire for greater accountability and corporate responsibility.

Technological Advancements and Innovation

When pharmaceutical manufacturing is brought back to the United States, there is a greater opportunity for innovation. Continuous manufacturing, advanced automation, and improved quality control systems are all more likely with a chain of domestic facilities. They are more likely to adopt cutting-edge technologies. These technologies increase efficiency, reduce costs over time, and enhance product consistency.

In contrast, many overseas facilities are slower to modernize due to limited capital investment or regulatory restrictions. Reshoring CMOs allows American firms to lead in pharmaceutical technology and manufacturing science.

Collaboration is strengthened: manufacturers, research institutions, and universities work together more naturally. The exchange of knowledge and technology accelerates innovation and shortens the time needed to bring new treatments to market.

Resilience in Times of Crisis

We have seen how vulnerable the global pharmaceutical supply chain can be. Recent events have led to delays, shortages, and rising prices. When companies rely too heavily on foreign suppliers, they lose the ability to adapt quickly to changing circumstances.

Creating a network of CMOs domestically increases resilience. Manufacturers will be able to launch emergency initiatives in a timely manner. They can adjust production levels or shift resources without waiting for overseas partners. This flexibility is essential during times of national crisis.

By investing in domestic capacity now, pharmaceutical companies can ensure they are prepared for the challenges of tomorrow. Reshoring is a long-term strategy that increases preparedness and stability.

Ethical and Environmental Considerations

Ethical labor practices and environmental standards can vary widely across different countries. CMOs may or may not operate under conditions that do not align with US values. There might be extremely low wages, unsafe working conditions, or limited environmental protections.

Bringing pharmaceutical manufacturing back to the US ensures compliance with fair labor laws and environmental regulations. Companies are required to provide safer working conditions and reduce their environmental impact. And consumers, in this case, patients, are increasingly interested in how products are made. These efforts support sustainability goals and improve corporate reputation.

Ethical sourcing and responsible production practices are no longer optional. Reshoring aligns with public expectations and supports the broader goal of corporate social responsibility.

I hope that after reading this, we all can agree that the decision to bring pharmaceutical CMOs back to the United States is both strategic and responsible. Offshore manufacturing has seemed to offer short-term cost savings. At the same time, it has created long-term risks related to quality, supply chain stability, and national security.

By investing in domestic production, the pharmaceutical industry can strengthen its foundation. Advantages include more reliable supply chains, enhanced quality control, stronger national security, economic growth, technological leadership, and ethical transparency.

Reshoring is certainly not without its challenges; it requires capital investment, workforce development, and regulatory planning. The long-term benefits do outweigh the initial costs. We can deliver safer, more reliable treatments to the people who need them most by producing more of our medications closer to home. And our industry will do all of that with a smaller footprint.

As the pharmaceutical industry faces growing complexity and rising public expectations, reshoring CMOs is a powerful step toward a more secure, transparent, and innovative future. The time has come to rebuild U.S. pharmaceutical manufacturing, for both economic reasons and the health and well-being of the nation.

If you are in a position to contract your organization's CMO and would like to discuss how to reshore manufacturing, please contact us at

hello@metisconsultingservices.com

Or for more information, see our website at:

https://www.metisconsultingservices.com/

Or better yet, schedule an appointment:

https://calendly.com/sbradley-metisconsultingservices