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FDA Regulatory
SJKP LLP’s FDA regulatory team provides expert guidance to leading medical device, pharmaceutical, and biotechnology companies—ranging from innovative startups to established public companies—navigating every phase of the FDA-regulated product lifecycle.
We offer strategic counsel on the most intricate and forward-thinking FDA issues. Our team helps clients with everything from developing global clinical trial strategies and managing pre-market approval processes to handling post-market enforcement actions and product recalls. By integrating legal expertise with deep industry knowledge, we provide clients with solutions that anticipate risks and support innovation.
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1. FDA Regulatory: Post-Market Compliance and Enforcement
SJKP LLP’s FDA regulatory group provides comprehensive advice at every stage of the product lifecycle. Whether working on clinical trials, product approvals, or market access, our team is equipped to handle the most challenging FDA issues that arise for life sciences companies. We understand the pressures businesses face when products are already in the marketplace and subject to heightened scrutiny.
Navigating Pre-Market and Clinical Trial Strategies
We help clients develop and execute global clinical trial strategies and pre-market approval plans to ensure smooth entry into the US market. Our deep understanding of FDA processes ensures our clients can successfully navigate the regulatory landscape to bring innovative medical products to market. We also advise on clinical trial agreements, data protection, and global coordination, minimizing the risk of costly delays.
Managing Post-Market Compliance and Recalls
Our attorneys guide clients through FDA inspections, warning letters, and product recalls. We provide strategies that minimize reputational harm while ensuring rapid corrective action. With proactive compliance programs, we help companies avoid enforcement triggers and maintain consumer trust.
2. FDA Regulatory: Legislative Advocacy and Government Affairs
Our team supports clients with post-market FDA compliance, including recalls, regulatory enforcement actions, and defending market access for their products. We work closely with litigation teams to defend our clients in administrative procedure cases and other FDA-related regulatory challenges.
Defending Market Access and Compliance
We defend clients in litigation involving FDA decisions, including challenges under the Administrative Procedure Act. Our team works to resolve regulatory disputes and secure continued market access, providing strategic counsel to mitigate risks and ensure compliance with FDA regulations.
Engaging with FDA and Federal Agencies
Our attorneys regularly engage with the FDA, DEA, and other agencies on behalf of clients. We provide advocacy that helps shape policy and guide regulatory interpretation, ensuring that client interests are represented in federal decision-making.
3. FDA Regulatory: Legislative Advocacy and Policy Development
SJKP LLP has been at the forefront of FDA legislative initiatives for the past two decades. We provide advice on FDA policy, draft rule-making comments, participate in hearings and panel meetings, and advocate for our clients before senior government officials and members of Congress. Our long-standing involvement gives us unique insight into the policymaking process and its direct impact on regulated industries.
Policy Engagement and Advocacy
We advise clients on upcoming regulatory changes, helping them prepare comments and submissions that influence FDA policy outcomes. Our advocacy ensures that client perspectives are considered when new regulations are crafted, strengthening their ability to operate within evolving frameworks.
Shaping the Regulatory Landscape
Through participation in advisory committees, legislative hearings, and industry coalitions, we help clients shape the conversation around FDA regulation. This proactive approach enables businesses to remain competitive and compliant as the regulatory environment evolves.
The information provided in this article is for general informational purposes only and does not constitute legal advice. Reading or relying on the contents of this article does not create an attorney-client relationship with our firm. For advice regarding your specific situation, please consult a qualified attorney licensed in your jurisdiction.
