Regulations: managing the balance of risk and rewards

Companies that work in the life science, advanced technology, and applied materials industries know that regulatory knowledge and support is critical to success. Whether a product or solution makes it to market—or even gets to the starting gate of R&D—can depend on how regulations are interpreted and followed. And with a constantly changing environment, staying up-to-date with regulatory expertise is more important than ever.

Some companies see regulations and compliance guidelines as hurdles to overcome. Avantor views them as a challenge to be met, with innovation and expertise. In highly regulated industries, we see opportunities to develop new technology, skills and data to serve our customers now and in the future.

Regulations and quality

In biopharmaceuticals, rapid global expansion and increased demand has heightened the need for close monitoring and regulation of every aspect of the process, from sourcing, to R&D, manufacturing and even marketing products. The specificity of more personalized medicine and single-use products requires sourced materials to be consistent in quality and purity—because even tiny inconsistencies can change the entire make-up of the product. Rigorous guidelines are necessary for patient safety.

In navigating the complexities of the single-use supply chain, Avantor has shown how we adapt to industry regulations to continuously improve the quality of our products. We are committed to operational excellence because the products we manufacture are directly affected by the processes we use. To fulfill that commitment, we offer unmatched customization of products and processes for our customers through our collaborative planning, forecasting and replenishment (CPFR) program.

We provide a high level of service to customers in highly regulated industries by:

  • Understanding customer needs
  • Streamlining documented requirements and processes
  • Staying in close contact with customers throughout the process to plan for and manage change
  • Adjusting processes to be flexible for regulations, product quality, and industry demands

Building collaborative relationships with our customers is about more than customizing products. It’s about developing expertise in manufacturing and regulatory that enables our customers to manage risk. And managing risk means more rewards.

Regulations expertise for risk management

Regulations are constantly changing to keep up with scientific advances. As companies expand to cover the process end-to-end, they need transparency and reliability from suppliers in order to manage their risk. How do companies in highly regulated industries balance risk and reward? By partnering with suppliers and service providers who can help mitigate risk through established expertise, global service and local support.

Avantor has built dedicated teams for regulatory expertise. Through Avantor Services, we can help our customers navigate the constantly changing world of compliance, reducing risks over time. Relying on years of industry expertise, our robust risk management process includes risk assessment, facility audits and deep analysis of every aspect of the supply chain. With our expertise, we can help our customers accomplish verifiable, documented compliance.

One of the hallmarks of our regulatory offering is “global reach, local support.” Avantor has 13 cGMP certified facilities, with standardized quality systems that ensure consistency and continuity all over the world. But we also understand that local facilities and expertise are required for success in highly regulated industries. Faster time-to-market creates challenges—the demand for finished products compels companies to carry large volumes of stock, but many do not have the proper facilities for warehousing. Our local, custom-designed storage facilities allow for quicker delivery, which solves this problem. And for companies that must manage complex local regulation processes, our on-site teams provide tailored advice and support.

Regulations advancing innovation

We advance our technology in response to our customers’ needs, so we can help them with improved product quality, more efficient processes, and positive regulatory outcomes. For example, we developed proprietary purification technology in order to maintain consistency and curtail variability in biopharmaceuticals production. Regulations can drive innovation even in areas that might seem mundane to the outside observer. In response to increased quality standards, we have designed packaging solutions and systems that help streamline manufacturing and decrease costs around regulatory compliance.

Meeting the challenges posed by regulations

Regulation is not an obstacle. It’s a challenge, and by working closely with our customers, we find more ways to rise to that challenge every day. At Avantor, we achieve operational excellence by collaborating with customers to understand their needs and build our services and technology to cater to them. We are continually adding to our expertise at global and local levels. As regulation raises the bar, it drives us to deliver innovative solutions for our customers’ needs, managing risks for greater rewards.