Regulatory
Government regulation has a profound impact on companies’ business operations and is a crucial factor in corporate strategic planning. In today’s environment of increasing oversight, regulatory frameworks are constantly evolving across sectors. As businesses face rising transparency pressures and increasing costs of non-compliance with laws and regulations, it is ever critical for businesses to endeavor to adapt to the growing pressure from regulatory bodies.
With our extensive knowledge of local regulations and multi-disciplinary experience and capabilities, Kendall PC is well-positioned to help clients deal effectively and creatively with regulatory issues. Our team of regulatory attorneys has worked in the industry and draws on this background to help our clients anticipate and adapt to the myriad regulatory and policy challenges that can arise at any stage of a regulated product’s lifecycle. We aid clients in highly regulated industry sectors in understanding their responsibilities, managing risk, and lessening the impact of complex regulatory regimes on their transactions or day-to-day operations.
The team of regulatory attorneys at Kendall PC offers comprehensive support to help clients navigate virtually any of the complex regulatory and compliance-related issues impacting regulated businesses, including matters involving US regulatory agencies such as the Food and Drug Administration (FDA), Federal Trade Commission (FTC), Department of Health and Human Services (HHS), and Department of Justice (DOJ); various business threats; regulatory and legislative guidance; fraud and abuse; and due diligence.
For more information about our regulatory practice, contact Kendall PC online or at (484) 414-4093. Our regulatory lawyers serve companies and organizations throughout the United States and across the globe.
Regulatory Strategy, Product Development, and Product Approvals
Taking an FDA-regulated product from initial concept development to regulatory approval or clearance presents a daunting array of challenges and opportunities. Kendall PC works with clients from the initial stages of a product’s life cycle. We represent a range of clients in all facets of FDA-regulated product development such as research institutions, contract research organizations (CROs), contract manufacturing organizations (CMOs), cosmetic companies, and pharmaceutical, medical device, and biotechnology manufacturers.
When providing counsel to clients on the submission of applications for regulatory approval, our regulatory attorneys assist in matters pertaining to:
- Labeling and promotion
- Eligibility for specialized and piloted review programs
- Clinical trials and data development
- Advisory committee preparation
- Post-market obligations
Our regulatory attorneys counsel and assist FDA-regulated companies in sponsored product research activities comply with federal laws and regulations and best practices relating to pre-clinical and clinical research, including FDA investigational new drug (IND) and investigational device exemption (IDE) requirements; human subjects’ protections; adverse event reporting (AE); clinical trial registration and reporting requirements; and research and material transfer agreement contractual negotiations.
We regularly assist clients with obtaining FDA approval or clearances with market protections where available and possible for prescription drugs, biologics, medical devices, and food additives. Our team of regulatory attorneys advises clients on the viable pathways to expedite agency review, including development and submission of INDs, NDAs, BLAs, ANDAs, IDEs, PMAs, and 510(k) applications for regulatory approval or clearance of drugs, biologics, and medical devices. We also assist clients in preparation for advisory committee proceedings, responding to agency correspondence, and appealing adverse decisions regarding clearance and approval.
Additionally, we assist clients in all aspects of food, beverage, and dietary supplement development including product formulation, safety, appropriate labeling, health claims as well as “structure/function” claims and Nutrition Labeling and Education Act of 1990 (NLEA) and Generally Recognized as Safe (GRAS) determinations.
Advertising and Promotion
The team of regulatory attorneys at Kendall PC understands the myriad of regulatory requirements and business interests that companies face in designing advertising and promotional initiatives and campaigns in commercializing their regulated products, including:
- Prescription drugs
- Medical devices
- Biologics
- Biotechnology
- OTC pharmaceuticals
- Food and beverages
- Dietary supplements
- Cosmetics
Whether pre-launch or post-market approval or clearance, we counsel clients on developing and maintaining compliant advertising and promotional strategies in compliance with FDA and FTC rules governing advertising and marketing amongst others. Our extensive experience and cross-disciplinary approach allow us to anticipate and mitigate legal risks across marketing campaigns.
Our team also provides support serving as legal representatives on a variety of PRC teams for prescription drugs, medical devices, and biotechnology products. Learn more about our Promotional Review Committee (Medical, Legal & Regulatory Review Promotional Review Committee (Medical, Legal & Regulatory Review Committee) services.
Kendall PC additionally assists clients in matters of government inquiry and competitor disputes regarding promotional and marketing practices, including responses to FDA Warning and Untitled Letters, FTC enforcement actions, state investigations, and Lanham Act matters.
FDA Guidance and Post-Approval Compliance
Kendall PC’s regulatory practice delivers complete, refined assistance to clients in all areas of FDA post-approval compliance. Our team supports nearly every aspect of clients’ regulated business activities and corresponding FDA compliance matters. We understand that accomplishing business goals in such a highly regulated industry requires practical, integrated legal analysis and advice. With widespread first-hand industry experience, Kendall PC knows the nuances of the law and understands the business, science, and marketplace challenges that inform post-market activities and compliance issues.
We provide support to FDA-regulated companies in their FDA compliance doings including:
- Developing effective U.S. and global compliance programs
- Preparing for inspections and managing ongoing inspections
- Analyzing and implementing Good Manufacturing Practices (GMPs) compliance
- Adhering to Quality System Regulations (QSR), including the development of corrective and preventative action (CAPA) plans
- Import/Export Requirements
- Managing Federal healthcare programs reporting requirements
- Addressing manufacturing site non-compliance
- Communicating with payors and formulary committees
Product Recall, Correction, Removal, and Supply Chain Matters
Product manufacturers and sellers in regulated industries are routinely responsible for notifying government officials and consumers when product issues arise. Kendall PC understands the complexities and challenges pertaining to product recalls in regulated industries. We have substantial experience assisting manufacturers, sellers, and distributors with best practices to remove and/or correct violative products. Our team of regulatory attorneys is experienced in successfully resolving high-exposure product recalls. We provide counsel to our clients to minimize the exposure and reputational risk to the company and reduce the potential for collateral litigation. Kendall PC assists clients in developing corrective action plans, interacting with government agencies involved in overseeing the recall, completing formal notification processes, deploying public relations plans, and implementing and managing the product recall or correction. Our regulatory practice routinely supports manufacturers and sellers to address business-to-business (B2B) recalls within the distribution channel, including responsibility for the defect; scope and division of responsibility for the corrective action plan; responsibility for third party claims; and responsibility for the recall expenses. We also aid companies with consumer recalls on all levels, including dealings with government agencies, distributors, retailers, and consumers.
Additionally, Kendall PC has extensive experience in providing practical counsel in initiating and managing market withdrawals.
Government Enforcement
Government enforcement actions and investigations can arise unexpectedly. Kendall PC has extensive experience in defending companies in the regulated sector in government enforcement matters. We handle regulatory agency enforcement correspondence, including managing investigations by federal and state government entities. We assist clients in developing strategies, mitigating risk, and providing critical and appropriate response and remediation efforts when necessary.
Our regulatory team of attorneys counsels clients on the following government enforcement matters:
- FDA Form 483 Responses
- Warning and Untitled Letter Responses
- Notices of Violations
- Warned Product Seizures
- US federal and state government civil investigative demands and administrative subpoenas
- Corporate Integrity Agreement (CIA) negotiations
Transactional Support
In connection with counsel on regulatory requirements and compliance, Kendall PC provides transactional support to clients in regulated sectors on structuring transactional arrangements for the research, clinical study, development, manufacture, and distribution of regulated products including prescription and OTC pharmaceutical products, medical devices, biotechnology, food, beverage, and dietary supplements. Additionally, we perform due diligence on corporate transactions and other partnership, joint venture, and strategic alliance matters involving regulated companies and the regulatory treatment of regulated products. Kendall PC understands the complex legal and business issues impacting companies operating in the regulated sectors and we have a depth of experience to help clients meet their business objectives. Learn more about our commercial contracting practice.
Contact Our Regulatory Lawyers Today
For more information about our regulatory practice, contact the regulatory lawyers at Kendall PC now online or at (484) 414-4093. Our distinguished firm proudly serves small, midsized, and emerging businesses throughout the United States and across the globe.
