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FDA Regulatory
Comprehensive Legal Counsel for Life Sciences, Food, and Healthcare Innovation
The FDA Regulatory landscape governs some of the most complex and highly scrutinized industries in the world, encompassing pharmaceuticals, biotechnology, medical devices, cosmetics, and food products. Companies that innovate in these sectors must not only meet scientific and commercial demands but also navigate a rigorous network of laws and policies enforced by the U.S. Food and Drug Administration (FDA).
At SJKP LLP, our FDA Regulatory practice helps clients anticipate, interpret, and comply with regulatory expectations across the product lifecycle—from concept and development to approval, commercialization, and post-market surveillance. We provide legal clarity and strategic foresight to companies seeking to innovate responsibly in an environment defined by safety, efficacy, and public trust.
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1. The Framework of FDA Regulatory Oversight
Understanding the Scope and Structure of U.S. Food and Drug Law
The FDA Regulatory framework ensures the safety, quality, and effectiveness of products that reach consumers and patients. Our lawyers assist clients in understanding this structure and aligning their internal processes with regulatory requirements.
FDA Jurisdiction and Statutory Authority
We advise clients on the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Public Health Service Act, and related statutes that empower the FDA to regulate products. Our FDA Regulatory team clarifies how classification decisions, labeling requirements, and enforcement mechanisms apply across industries, helping clients determine which division or center of the FDA will oversee their product.
Product Classification and Regulatory Pathways
We assist companies in determining whether their product is a drug, device, biologic, combination product, or dietary supplement. Our lawyers guide clients through the appropriate regulatory pathway, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), Biologics License Applications (BLAs), and 510(k) or PMA submissions for medical devices.
2. FDA Regulatory Compliance Throughout the Product Lifecycle
Advising on Development, Manufacturing, and Commercialization
Compliance with FDA Regulatory requirements begins long before a product reaches the market. Our firm advises clients on strategies that integrate compliance into every stage of development, ensuring speed without compromising safety or legal integrity.
Clinical Trials and Research Integrity
Our lawyers counsel sponsors, investigators, and contract research organizations (CROs) on clinical trial design, informed consent, and data integrity. We help secure FDA clearance for INDs and Investigational Device Exemptions (IDEs) while managing reporting and monitoring obligations under Good Clinical Practice (GCP) standards.
Manufacturing, Labeling, and Advertising Compliance
We assist with compliance under current Good Manufacturing Practices (cGMPs) and Quality System Regulations (QSRs). Our FDA Regulatory practice reviews labeling, marketing, and promotional materials to ensure compliance with FDA and Federal Trade Commission (FTC) rules. We also advise on social media and digital marketing practices for regulated products.
3. FDA Regulatory Approvals, Submissions, and Communications
avigating Approval Processes and Regulatory Engagement
Effective engagement with the FDA is critical for companies seeking timely approval and sustainable compliance. Our FDA Regulatory lawyers help clients prepare persuasive submissions and maintain productive communication with the agency.
Pre-Submission Strategy and Regulatory Meetings
We advise clients on pre-submission consultations with the FDA, including Pre-IND and Pre-Submission (Q-Sub) meetings. Our team helps define regulatory strategies, anticipate agency feedback, and build documentation that supports approval goals while minimizing delays.
Market Authorization and Post-Approval Requirements
We guide companies through the submission and review process for NDAs, BLAs, 510(k)s, and PMAs. Our FDA Regulatory lawyers also assist with post-market surveillance, adverse event reporting, and compliance with risk evaluation and mitigation strategies (REMS). We ensure our clients maintain strong relationships with regulators throughout the product lifecycle.
4. FDA Regulatory Enforcement, Investigations, and Litigation
Managing Risk, Responding to Agency Action, and Protecting Reputation
FDA enforcement can have significant financial and reputational consequences. Our FDA Regulatory team provides immediate and strategic support during investigations, inspections, and enforcement proceedings.
FDA Inspections and Warning Letters
We represent clients during FDA inspections, advising on inspection readiness, investigator interaction, and response strategies. Our lawyers assist with drafting responses to Form 483 observations and warning letters, ensuring prompt and thorough corrective action plans that mitigate enforcement risk.
Administrative, Civil, and Criminal Enforcement Defense
Our team defends clients facing seizures, injunctions, and criminal investigations related to alleged violations of FDA laws. We also handle False Claims Act (FCA) and qui tam cases involving regulatory compliance issues. When necessary, our litigation lawyers collaborate with our FDA Regulatory team to achieve favorable resolutions through negotiation or litigation.
5. Emerging Issues in FDA Regulatory Science and Policy
Adapting to Innovation and Legislative Change
The pace of scientific innovation requires constant adaptation of FDA Regulatory frameworks. Our firm helps clients anticipate new developments and engage in policy discussions that shape the future of regulation.
Digital Health, Artificial Intelligence, and Software Regulation
We advise companies developing AI-driven medical devices, software as a medical device (SaMD), and digital therapeutics. Our lawyers assist with classification, premarket submission, and post-market monitoring requirements for software products regulated by the FDA.
Personalized Medicine, Cell and Gene Therapies, and Advanced Technologies
Our FDA Regulatory practice supports life sciences companies working on personalized medicine and advanced therapeutic platforms. We help navigate emerging policies governing genetic testing, regenerative medicine, and accelerated approval pathways. We also advise on post-approval obligations related to manufacturing, tracking, and safety monitoring.
6. Why Choose SJKP LLP for FDA Regulatory
Regulatory Precision. Scientific Understanding. Strategic Advocacy.
At SJKP LLP, we understand that success in FDA Regulatory matters depends on deep technical knowledge and an ability to translate science into legal strategy. Our lawyers have experience in industry, government, and academia, giving clients an unparalleled perspective on regulatory expectations and industry best practices.
We assist startups, global pharmaceutical leaders, and technology innovators with product development, compliance, and enforcement defense. Our multidisciplinary approach integrates expertise in life sciences, intellectual property, litigation, and corporate transactions to provide clients with a 360-degree perspective on FDA-regulated industries.
Whether securing approvals for breakthrough therapies, defending against enforcement actions, or shaping policy dialogue, SJKP LLP delivers the insight, advocacy, and reliability that clients need to succeed in today’s FDA-regulated world.
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.
Certain informational content on this website may utilize technology-assisted drafting tools and is subject to attorney review.
