State Licensing Services & the Future of Third-Party Logistics
Federal and state laws regulate all aspects of manufacturing, distributing, and dispensing prescription drugs. For drug manufacturers, adhering to these regulations can be complex and time-consuming, given the varying requirements and processes across states as well as the need for periodic license renewals.
Correctly managing state licensing is an integral part of a specialty pharmaceutical manufacturer’s business. Third-party logistics (3PL) partners can often help navigate these ever-changing regulations and requirements to ensure smooth and compliant distribution of life-saving therapies.
As an expert in specialty pharmaceutical distribution, LogiCare3PL offers comprehensive state licensing services that streamline the process across multiple states and reduce the risk associated with licensing discrepancies.
If a 3PL partner is offering state licensing services, ensure they have expertise in:
Quality and regulatory requirements
A team with deep knowledge of quality and regulatory requirements is a critical asset when working with a 3PL provider. Due to the complex handling requirements of specialty pharmaceutical products, they are governed by US Food & Drug Administration (FDA) regulations to ensure quality. In addition, 3PL providers that handle specialty pharmaceutical products must be in compliance with Current Good Manufacturing Practice (cGMP) regulations. It is imperative to work with a 3PL partner with extensive experience in compliance with both of these requirements and that understands how to navigate the complex and unique landscape.
Regulatory monitoring
The specialty pharmaceuticals industry is constantly evolving due to the frequent shifting of regulations, requirements, and best practices. It is crucial to stay up to date in this dynamic landscape by maintaining compliance and ensuring adherence to the latest rules and regulations.
A 3PL can proactively monitor for new state and federal regulations to ensure its manufacturing partners stay abreast of changes. LogiCare3PL’s tenured team of experts provides its partners with in-depth analysis and guidance to ensure compliance despite shifting regulations.
Continuous compliance
Renewals and registration updates are additional aspects of compliance that specialty manufacturers need to stay on top of. With regulations varying by state and separate federal requirements, there are multiple bodies to keep up with.
LogiCare3PL works to ensure continuous compliance for its partners by managing renewals in a timely manner according to each state’s specific requirements, as well as handling registration updates for state licenses.
Regulatory compliance
To stay compliant, specialty pharmaceutical companies must report to each state any significant company events like changes to ownership, location, offices, or directors. Amidst a big change, this reporting might not be top of mind. However, it is crucial for compliance with state and federal regulations. A 3PL partner that offers state licensing services, like LogiCare3PL, can facilitate regulatory compliance by handling the reporting of these events.
Partnering with a 3PL provider that understands specialty product needs and the robust regulatory landscape is an asset to a pharmaceutical manufacturer. LogiCare3PL has a tenured team with expertise in licensing and compliance, allowing its partners to benefit from a streamlined licensing process and minimizing risk to ensure patients receive life-saving therapies on time.
Let the experts handle compliance and regulatory requirements for state licensing. Take a look at LogiCare3PL’s comprehensive list of capabilities, including state licensing services. Learn more.