Partnering With a 3PL to Break Through Complex Regulatory and Compliance Challenges in Life Sciences

The COVID-19 pandemic brought to the forefront a fact many supply chain managers and professionals already knew: supply chains are complex systems that continually evolve and need to be properly managed and controlled. Even the best managed supply chains can be impacted by unforeseen risks, product shortages and changing customer and market demands if vigilance is not maintained.

This is especially true for life sciences and healthcare supply chains, which have been particularly challenged throughout the pandemic. But even after the pandemic threat has diminished, one of the major sources of complexity and risk for life sciences and healthcare supply chains will remain – regulatory and compliance risk.

生命科学和医疗保健公司在运作one of the most regulated environments, subject to an ever-changing and growing set of regulations and compliance requirements that vary between countries, regions, states, product classifications and even industries. The challenge is trying to comply with these regulations and requirements without sacrificing efficiency, uptime and cost effectiveness.

Partnering and working closely with the right third-party logistics provider can help streamline and simplify regulatory compliance. It needs to be a 3PL that can anticipate and adapt to change efficiently through data-driven insights, customer-focused associates and scalable resources. One that seamlessly pairs logistics expertise with your product expertise. Such a provider can offer a significant advantage to companies looking to maximize the value of their supply chains while minimizing potential compliance risk stemming from those supply chains. Following are four ways a 3PL can provide value.

1. Compliance:As life sciences and healthcare supply chains scramble to keep up with changing market conditions, it can often be easy to lose track of which products are governed by regulations, which licenses are required and what steps need to be taken to stay compliant. A 3PL with life sciences and healthcare experience and expertise should be able to identify relevant regulations and compliance requirements for products and determine which registrations or permits are required. A good partner can also monitor any regulatory changes with regulators. This can be especially important at the state and federal levels. Since all states act independently, the product could be governed by regulations not only where it is produced, but also where it is shipped and stored.
2. 管理经验:Keeping pace with the ever-changing regulatory environment is a constant challenge as requirements are continually shifting. Along with tracking and providing visibility to the regulatory environment, the right 3PL partner has the ability to manage the process, navigate through the different requirements and work with the appropriate officials, whether they be from industry groups, federal agencies or state governments. A 3PL with a broad geographic network can help develop a strategy that provides the operational consistency and governance needed to keep products and supplies moving.
3. Flexibility, Scale and Speed to Market:The more complex the supply chain, the more regulations and compliance issues that may need to be addressed. That is why it is important to partner with a 3PL that has an established network scale and geographic breadth that gives them first-hand experience and knowledge of regulations in various regions. This is just as vital at the global level as it is at the state and local level. A 3PL that is adept at leveraging the value of scale can provide the flexibility needed to take advantage of local regulatory changes, enter new markets and geographic locations and capitalize on evolving market trends or opportunities. It can also help ensure that quality assurance and regulatory requirements are not compromised while regulatory risk is reduced.
4. Remove Boundaries to Excellence in Quality and Compliance:Life sciences and healthcare supply chains require the upmost precision. One misstep or failure, regardless of how small or momentary, can have damaging effects on a company, including lost revenue, product shortages, fines and legal actions and damaged reputation. This is why it is vital to work with a 3PL that has a focus on life sciences and healthcare and exhibits deep market knowledge. The provider should also have regulatory and compliance expertise and experience that covers all subsectors, including medical devices, pharmaceuticals, consumer healthcare, cosmetics and over-the-counter drugs and devices. It also helps if that 3PL is able to integrate additional supply chain services and value, including warehousing, transportation, real estate, packaging, innovative technology, data analytics and a skilled workforce.

Regulations and compliance issues are an increasingly complex challenge for most life sciences and healthcare supply chains – one that requires significant focus and expertise to successfully navigate. Partnering and working closely with the right 3PL can help ensure compliance is properly managed, risks are mitigated and costly missteps are avoided.

For more information on DHL Supply Chain’s life sciences and healthcare expertise and solutions and services, visithttp://app.supplychain.dhl.com/e/er?s=1897772577&lid=8360.