Fractional In-House Counsel

At MyFDALawyers.com, PC, we provide fractional in-house counsel services to FDA-regulated businesses nationwide. Our attorneys have worked closely with a wide range of FDA-regulated businesses for more than two decades. We take a proactive, solutions-focused approach. If you have any questions about our fractional in-house counsel services, please do not hesitate to contact us today for a confidential consultation.

What is a Fractional In-House Counsel?

FDA-regulated businesses benefit from professional legal representation. However, having a full-time attorney on staff is often not financially feasible or advantageous. At MyFDALawyers.com, PC, we provide cost-effective fractional in-house counsel services.

A fractional in-house counsel is an experienced attorney who provides ongoing legal support to a business on a part-time or as-needed basis. That means firms get access to a lawyer who actually understands your business without the cost or commitment of hiring full-time, in-house legal staff. It is an arrangement that offers many benefits.

How FDA-Regulated Businesses Benefit from Fractional In-House Counsel

For FDA-regulated businesses, the fractional in-house counsel model offers consistent legal guidance on regulatory compliance, contract review, labeling and marketing claims, and managing FDA enforcement risk. Our firm offers fractional in-house counsel services tailored specifically for companies in the food, supplement, cosmetic, OTC drug, and medical device industries. Whether you are a startup preparing to launch a product or an established brand scaling operations, the right in-house counsel can make the difference.

An Overview of Our Fractional In-House Counsel Services. 

We are committed to providing top-quality, cost-effective fractional in-house counsel support that all types of businesses can rely on. We help you manage day-to-day regulatory risks, respond to FDA inquiries, develop and maintain compliance systems, and review marketing materials for claim substantiation. A selection of our services includes:

• Market Entry: We guide businesses through the regulatory requirements for legally introducing FDA-regulated products into the U.S. market. Among other things, this includes product classification analysis, premarket filings, and identifying the appropriate compliance pathway. Our attorneys help ensure that your launch is legally-sound, your product and its marketing claims rest on a solid regulatory foundation so that you’re able to focus on growing the business.
• FDA Registrations: We assist with all required FDA registrations and listings for facilities, products, and U.S. agent requirements for food, supplement, cosmetic, drug, device firms. Among other things, this includes submission of annual renewals, changes in ownership or location, and compliance with foreign supplier requirements.
• Contracts: We draft and review manufacturing agreements, private label contracts, and supplier/distributor arrangements. Each contract allocates both regulatory responsibilities and risks comprehensively and consistent with your risk profile and commercial agreement. We focus on protecting your business through clear language, strong advocacy, and practical provisions.
• Regulatory Due Diligence: We provide legal analysis for transactions in regulated products (e.g., mergers, acquisitions, asset sales) by assessing regulatory risks and compliance gaps. This includes reviewing labeling, registration status, inspection history, and any prior enforcement activity. Our due diligence services are designed to address problems before they arise.
• FDA Inspections: We prepare clients for upcoming inspections and offer real-time support during site visits, including remote guidance or attorney attendance. We help manage FDA communications, ensure staff readiness, and develop response strategies for all types of agency interactions.
• Label and Claims Review: We review product labels, websites, packaging, and marketing materials for FDA and FTC compliance. Among other things, this includes ensuring mandatory information is accurate and that claims are properly substantiated.
• FDA Detentions: When FDA detains imported products, we act swiftly to evaluate the detention notice, prepare persuasive responses, and seek release of the goods to reduce the likelihood of FDA Refusal. Our approach is rooted in demonstrating legal compliance and correcting procedural missteps to attempt get your goods released quickly.

Why Trust Us for Fractional In-House Counsel

Bill Senior and Rick D. Quinn are business lawyers focused exclusively on FDA-regulated products and businesses. For more than two decades, they have worked closely with a wide variety of different companies, from small start-ups to large corporations. At MyFDALawyers.com, PC, we are ready to serve as your in-house counsel. Our team provides proactive representation that is designed to address and resolve federal and state regulatory matters at the earliest possible stage—ideally before they ever become a real issue. With our law firm, you will get access to fractional in-house counsel who offers: