Wolters Kluwer CT Corporation podcast forecasts expanding compliance challenges within the pharmaceutical industry

Rhea-AI Summary

Third party logistic providers (3PLs) face increasing compliance challenges due to a proposed FDA rule aimed at standardizing regulations across states. This may result in tighter restrictions for both pharmaceutical companies and 3PLs. Hans Howk from Wolters Kluwer CT Corporation advises 3PLs to engage trusted partners for tracking evolving regulations. Wolters Kluwer has been a leading provider in compliance services for nearly 130 years, trusted by a large portion of Fortune 500 companies and law firms.

Positive

• Wolters Kluwer's longstanding experience in compliance services, with nearly 130 years in the market.
• Trust from over 75% of Fortune 500 companies and 95% of AmLaw 100 law firms highlights strong market credibility.

Negative

• Proposed FDA rule may lead to increased regulatory burdens for 3PLs and pharmaceutical companies.

Third party logistic providers may encounter new difficulties in an already complex regulatory landscape

NEW YORK--(BUSINESS WIRE)-- Third party logistic providers (3PLs) that facilitate warehousing, shipping and other logistic services for pharmaceutical manufacturers or wholesale distributors have likely grown accustomed to the rigorous demands of a tightly-regulated industry. But according to a recent installment of Wolters Kluwer CT Corporation’s Expert Insights podcast, 3PLs already struggling to contend with a multitude of state regulations could find their compliance burden intensifying in the face of a proposed rule announced by the U.S. Food and Drug Administration earlier this year.

Hans Howk, Manager of Content Management at Wolters Kluwer CT Corporation, explains that most states maintain some variation on a third party logistics license, with 3PLs forced to track and comply with a complex web of requirements spanning each state in which they do business. Depending on the jurisdiction involved, 3PLs may be asked to provide a wide range of materials that includes contract samples, customer states, proof of general liability insurance or the names and addresses of all partners and major shareholders.

To bring some consistency to the landscape, the FDA announced a proposed rule in February designed to ensure that all states are regulating the drug supply chain in a strict and unified manner – but Howk suggests that this may ultimately tighten regulations for pharmaceutical companies and 3PLs alike. He recommends that 3PLs engage the services of a trusted partner who can track evolving regulations, submit license applications, and execute pending renewals.

“Engaging the services of a trusted partner such as CT Corporation to centralize and manage these processes allows third party license providers to focus on running their business,” Howk said.

For nearly 130 years, Wolters Kluwer CT Corporation has been the leading provider of registered agent services, incorporation services, and legal entity compliance. It is part of Wolters Kluwer’s Governance, Risk & Compliance (GRC) division and has a global reach into over 150 countries. More than 75 percent of Fortune 500 companies, 95 percent of AmLaw 100 law firms, and 350,000 small businesses trust CT Corporation to handle their compliance needs. The other legal services business of Wolters Kluwer GRC is Wolters Kluwer ELM Solutions – a global provider of enterprise legal spend and matter management, contract lifecycle management and legal analytics solutions.

About Wolters Kluwer Governance, Risk & Compliance

Governance, Risk & Compliance is a division of Wolters Kluwer, which provides legal and banking professionals with solutions to help ensure compliance with ever-changing regulatory and legal obligations, manage risk, increase efficiency, and produce better business outcomes. GRC offers a portfolio of technology-enabled expert services and solutions focused on legal entity compliance, legal operations management, banking product compliance, and banking regulatory compliance.

Wolters Kluwer (WKL) is a global leader in professional information, software solutions, and services for the healthcare; tax and accounting; governance, risk and compliance; and legal and regulatory sectors. We help our customers make critical decisions every day by providing expert solutions that combine deep domain knowledge with specialized technology and services. Wolters Kluwer reported 2021 annual revenues of €4.8 billion. The group serves customers in over 180 countries, maintains operations in over 40 countries, and employs approximately 19,800 people worldwide. The company is headquartered in Alphen aan den Rijn, the Netherlands.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220826005048/en/

Media Contacts for Wolters Kluwer GRC

(including Wolters Kluwer CT Corporation, Wolters Kluwer ELM Solutions, Wolters Kluwer Compliance Solutions and Wolters Kluwer Finance, Risk & Regulatory Reporting)

Paul Lyon

Senior Director, Global Corporate Communications: Global Marketing, Communications & Planning

Governance, Risk & Compliance Division

Wolters Kluwer

Office +44 20 3197 6586

Paul.Lyon@wolterskluwer.com

Frank Ready

Senior Specialist, Corporate Communications, Legal Services

Governance, Risk & Compliance Division

Wolters Kluwer

Office 717-205-3647

Frank.Ready@wolterskluwer.com

Source: Wolters Kluwer

FAQ

What is the impact of the proposed FDA rule on WTKWY's compliance services?

The proposed FDA rule may increase regulatory burdens for third-party logistic providers and their clients, potentially impacting WTKWY's compliance services adversely.

How does Wolters Kluwer support logistics providers with compliance?

Wolters Kluwer offers compliance tracking, license application submissions, and renewal executions to assist logistics providers.

What percentage of Fortune 500 companies rely on Wolters Kluwer?

Over 75% of Fortune 500 companies trust Wolters Kluwer for their compliance needs.

Who is Hans Howk and what is his role regarding compliance challenges for 3PLs?

Hans Howk is the Manager of Content Management at Wolters Kluwer CT Corporation and discusses the compliance challenges faced by 3PLs.

In what ways can 3PLs navigate the complex regulatory landscape?

3PLs can navigate the landscape by engaging trusted partners like Wolters Kluwer to manage compliance effectively.