C. HUMPHREY & ASSOCIATES
FDA Lawyers and Consultants
We handle all FDA Sectors so you don’t have to
3 Reasons to Choose Us
We have more than three decades of technical and regulatory experience that is not typically found in small to mid-sized regulatory law firms. Our team consists of former FDA investigators, compliance officers, and industry consultants who have experience in all FDA regulated industry sectors.
Our law firm philosophy centers on service. We are responsive to the needs of our clients (whether small, medium or large) and to move their business goals forward. We believe that timely, personal attention is the hallmark of quality legal service, and we apply this to all of our clients.
Our team is passionate about helping our clients attain their goals, and we are committed to addressing the needs of our clients in the most efficient and cost-effective manner. We provide a cost-effective billing model tailored to the needs of each client.
FDA Regulatory Compliance with C. Humphrey & Associates, P.A.
The Food and Drugs Act of 1906 was the first of more than 200 laws that constitute a comprehensive and ever changing regulatory authority of the U.S. Food and Drug Administration (FDA). Examples of recent FDA legislative enactments include:
- The Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law on July 9, 2012, gives FDA the authority to collect user fees from industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics;
- The FDA Safety and Innovation Act (FDASIA) includes the Medical Device User Fee Amendments of 2012 (MDUFA III) as well as user fees paid to the FDA by medical device companies when they register and list. FDASIA changes how the FDA approves clinical trials and provides a new de novo pathway for risk-based classification of devices;
- The FDA Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011 and reforms U.S. food safety requiring new registration and preventive control requirements for domestic and foreign food manufacturers and distributors;
- The Family Smoking Prevention and Tobacco Control Act of June 22, 2009, commonly referred to as the Tobacco Control Act gives FDA authority to regulate the manufacture, distribution, and marketing of tobacco products;
FDA regulates products accounting for roughly 25% of the United States gross national product – $1 trillion worth of products a year.
The practice of C. Humphrey & Associates P.A., is one of only a few law firms in the United States, led by Christine M. Humphrey, Esq., a former FDA investigator and FDA compliance officer, that concentrates primarily on FDA law, trade and regulatory compliance.
Our expertise extends to foods and dietary supplements, medical devices, pharmaceuticals, OTC drugs, biologics, biotechnology, animal feeds and drugs, cosmetics, and electronic radiation products. Our FDA attorneys and FDA consultants provide proactive guidance to domestic and foreign clientele on product compliance reviews, labeling, product clearances and approvals, promotion and advertising, exports and imports, MDR reporting, QSR and cGMP requirements, preparation for FDA inspections and meetings. We respond to regulatory and enforcement actions including FDA483s, warning letters, injunctions, prosecutions, detentions, refusals, Customs penalties and FDA import alerts.
We distinguish ourselves in our ability to handle the most complex legal matters, while providing clients with a close, personal service often nonexistent in larger firms. Our FDA lawyers and FDA consultants pride themselves on their flexibility, efficiency and responsiveness.
C. Humphrey & Associates, P.A. provides clients with an initial consultation at no charge. This allows our FDA attorneys and FDA consultants to determine the issues and scope of work necessary for providing effective and cost-efficient regulatory and compliance based legal services. Following the initial consultation, our FDA attorneys and FDA consultants will assess the scope of work. We realize that companies need to plan and budget for legal services and therefore we render our legal services under the following fee structure.
Our retainer replenishment provides clients with the option of replenishing their retainer at an agreed upon amount once the retainer is fully utilized. The retainer replenishment structure requires an initial non-refundable retainer upon engagement. Our firm provides the client with notice once the retainer nears depletion and the retainer is required to be replenished at an agreed upon retainer amount upon notice of depletion.
This structure allows the client to control the utilization of fees for services rendered and collaborate on each matter status with our firm at the time notice is provided that the retainer funds are near depletion. Retainer replenishment of the established retainer fee is required for continued representation. Expenses are billed separately.
All invoices are electronically generated and delivered via e-mail for your convenience. Invoices display line item descriptions of service rendered, hours, rates, staff, expenses, retainer balance, payment allocations, and more.