Advocacy With FDA
We are involved in meetings and appeals of all kinds. We assist clients with difficult or intractable FDA investigators. We also attend local District Office meetings to meet with the District Director on inspectional or enforcement matters. Our specialty is taking clients to the Center in Silver Spring, Maryland for meetings of all kinds, including Pre-IND/IDE, Pre-Submission Meetings, informal meetings and formal appeals under 21 C.F.R. 10.75, Part 15 hearings, as well as negotiations on warning letters and other enforcement matters, clinical trials and performance data, 510(k)s, de novos, PMAs, combination products, HDEs, Orphan Drugs and ANDA/NDAs.
We are nice enough and good enough to be at the watercooler with you. We can fill in and provide you with a very high level of expertise and experience because our regulatory lawyers have all worked at companies of varying sizes and on the widest possible array of issues. We serve on development teams and provide regulatory support, draft device modifications justifications, work on recalls and Part 806 reports of corrections and removals, assist on inspections and cGMP/QSR issues, review labels and labeling, and help on exports and import holds.
Pre-Clinical and Clinical
We frequently work with clinical trial sponsors on clinical trial contracting and compliance. We assist clients in their contractual needs of their pre to post-market research endeavors, including observational studies, registries, interventional clinical trials, and investigator-initiated research. We also help clients understand their regulatory requirements for being a sponsor of an FDA-regulated clinical trial.
We play the role you choose, but our input is always experienced, strategic, and collaborative. DuVal & Associates routinely works with clients to obtain FDA approval or clearance for FDA regulated products. We can prosecute your submission in a turnkey fashion or simply be part of the support team. You can ask us to be out front, behind the scenes, or as an advisor - so the FDA knows we are involved. We work on Pre-INDs, pre-IDEs and INDs, IDEs Pre-Submission meetings, 510(k)s, PMAs, De novo Petitions, HDEs and Orphan Drugs, NDAs and ANDAs, Combination Product Requests for Designations and EU technical files.
Advertising and Promotion
We've "been there, done that." DuVal & Associates regularly advises clients on issues relating to the labeling, advertising, and promotion of FDA-regulated products, including pharmaceuticals and biologics, medical devices, dietary supplements, among others. Our attorneys have worked in industry. We understand what it takes to launch new products, and develop prescriber and patient advertising campaigns using the latest technical advances, such as websites, social media, paid search, and micro blogging, in a compliant fashion that considers current FDA thinking.
We help you identify and address problem areas: from compliance programs to due diligence. DuVal & Associates helps companies construct compliance programs, train management and sales organizations and conduct compliance assessments. Because we have been in-house, we understand the varying sensitivities and reactions to compliance programs how to implement them by effectively addressing cultural change.
When you're involved with government enforcement, you don’t want someone on their first rodeo. DuVal & Associates commonly counsels clients in enforcement actions brought by the FDA, DOJ, and various state agencies. We assist companies on matters involving alleged violations of the Food, Drug, and Cosmetic Act, among other laws. This may involve FDA inspections alleging serious cGMP or QSR violations, claims of a failure to file a new 510(k) for a device modification, a promotional violation, or a clinical trial conduct violation.
We engage in on-site training for many of our clients. We train management teams on promotional and HIPAA compliance. We do white boarding sessions with management to blue sky promotional opportunities. We work with regulatory staff on the same issues, as well as on how make effective submissions, device modifications, recalls and the like. We have spoken at hundreds of sales meetings.