Partnering with a 3PL to Address Complex Regulatory and Compliance Challenges in Life Sciences

A 3PL that understands how to leverage the value of scale can provide the necessary flexibility to capitalize on local regulatory changes, enter new markets and geographic locations, as well as capitalize on evolving market trends or opportunities

Fremont, CA: The COVID-19 pandemic brought to light something that many supply chain managers and professionals already knew: supply chains are complex systems that are constantly evolving and should be managed and controlled properly. Even the best-managed supply chains can be impacted by product shortages, unforeseen risks, and changing customer and market demands if vigilance is not maintained.

Following are ways a 3PL can provide value.

Regulatory Expertise: It is difficult to keep up with the ever-changing regulatory environment as requirements shift. The right 3PL partner can manage the process, navigate through the different requirements, and collaborate with the appropriate officials, whether from federal agencies, industry groups, or state governments, in addition to monitoring and reporting on the regulatory environment. A 3PL with a large geographical network can help develop a strategy that provides the operational consistency and governance needed to keep products and supplies moving.

Flexibility, and Speed to Market: More regulations and compliance issues may arise as the supply chain becomes more complex. 

That is why it is crucial to work with a 3PL that has a well-established network scale and geographic breadth, providing first-hand experience and knowledge of regulations in different regions. This is critical at the global, state, and local levels. A 3PL that understands how to leverage the value of scale can provide the necessary flexibility to capitalize on local regulatory changes, enter new markets and geographic locations, as well as capitalize on evolving market trends or opportunities. It can also assist in making sure that quality assurance and regulatory requirements are not jeopardized while lowering regulatory risk.

Compliance: As the life sciences and healthcare supply chains scramble to keep up with evolving market conditions, it is easy to lose track of which products are regulated, which licenses are required, and what steps should be taken to remain compliant. A 3PL with experience and expertise in life sciences and healthcare should be able to recognize relevant regulations and product compliance requirements, as well as which registrations or permits are required. A good partner will also keep regulators up to date on regulatory changes. This is especially true at the federal and state levels. Due to the fact that each state operates independently, the product may be subject to regulations not only where it is manufactured, but also where it is shipped as well as stored.