The pharmaceutical industry is no stranger to complex regulations, but recent tariff policies have added another layer of complexity and urgency, leading to a significant increase in required documentation and resulting action. One LinkSquares pharma customer, dealing with drug products, clinical trials, and regulatory compliance, including importing chemical reference standards and managing observational studies, is experiencing the tariff pivot in real time. They're facing a surge in amendments and the need for extensive executed document analysis to ensure compliance, describing it as "tariff nonsense" that has caused delays. Luckily, LinkSquares Sr. Customer Success Manager, Ariana Hajmiragha, is on the case.
Ariana is a dazzling CSM. She is also not a lawyer, and giving legal advice would be both inappropriate and illegal. But what she can do is expertly outline how LinkSquares can be leveraged as a powerful tool, as directed by the pharma company’s internal legal team. The company's Legal Counsel shared their specific challenges, and Ariana demonstrated how LinkSquares can effectively support their efforts.
Due to changes in regulations, the de minimis exception was revoked; meaning, for this Pharma customer, anything less than $800 is now subject to inspection. This necessitates extensive documentation even for small imports. He cited an instance where importing just 4 grams of reference standards required 10 pages of documentation for Customs and Border Protection and the FDA. This documentation includes identifying the items, their intended use, and the exporting company's DUNS number – a process the customer described as "absolutely crazy."
This pharmaceutical company deals with drug products, clinical trials, and regulatory compliance, including importing chemical reference standards and managing agreements for observational studies. They’re already utilizing LinkSquares for contract management, running reports, utilizing metadata extractions, and tracking contract adjustments. They plan to expand its use to manage amendments to clinical trial agreements and compare contract provisions in CDAs to update their templates.
Here’s how Ariana recommended using LinkSquares to navigate the new tariff landscape.
For ensuring compliance:
For Efficiently Drafting & Managing Amendments:
By leveraging LinkSquares, pharmaceutical companies can transform the "tariff nonsense" into a manageable process, ensuring compliance and maintaining operational efficiency in an ever-evolving regulatory environment.
Side bar: Schedule a demo for these exact features, and how LinkSquares can help create strong contracts for tariffs – and everything else!
Companies are adjusting to these tariffs in real time, LinkSquares just helps make sense of the noise. By strategically employing LinkSquares, pharmaceutical companies can effectively transform the "tariff nonsense" into a streamlined, manageable process. This powerful platform ensures compliance with ever-evolving regulatory demands but also upholds operational efficiency, allowing businesses to focus on their core mission rather than getting bogged down in extensive documentation. LinkSquares empowers legal and compliance teams to navigate complex tariff landscapes with confidence and precision. Pair it with a stellar CSM like Ariana, and you can take on any legislative or market change. In fact, 93% of users said they would recommend LinkSquares to others.
The landscape is changing, LinkSquares helps you manage whatever comes your way. Learn how today!