Regulatory Support

Regulatory Support

We are nice enough and good enough to be at the watercooler with you. Most of our clients simply want our expertise for difficult questions or circumstances. They call us to pick our brains, reassure themselves, or get advice they cannot get anywhere else. Many of our clients are virtual and need consultants to play critical short-term roles in making submissions, acting as a compliance officer, or sitting as a designee on a promotional review team. Other clients are between employees and have the same needs as they search for new or replacement talent, and require short-term assistance for issues such as writing a device modifications opinion, opining on a cGMP issue, determining whether a medical device report must be filed, or working on a drug or device recall. In any and all cases, 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.

Routine assignments include:

  • We serve on development teams and provide regulatory support - We help you integrate the disciplines of R&D, marketing, clinical, regulatory, and reimbursement to develop a product, a submission and claims matrix that meet the needs of FDA and get you the traction needed in the marketplace with the claims you need to make it differentiable and reimbursable.
  • Device modifications - We help with decisions on whether a product change requires a regulatory submission or a letter-to-file. We write thorough opinions to help you defend that decision later if necessary. We understand FDA's Modifications Guidance and are used to debating with the FDA over these types of issues.
  • Recalls and Part 806 reports of corrections and removals - We understand the interplay between all of FDA's statutes and regulations as it relates to recalls and, for medical devices, how to file and what to report in a Part 806 report of a correction or removal (or whether a report needs to be filed at all). We also help you understand how the local FDA District Office works on recalls and what their expectations are. We'll help you implement your strategy and deal with the FDA recall coordinator.
  • cGMP/Quality Systems issues - We help you to prepare for an inspection and we can audit your facilities with our non-attorney associates who have decades of experience auditing FDA-regulated companies. We keep up with FDA's latest initiatives.
  • Inspections - We can be there when you are inspected or be available by phone. We help you understand what FDA is entitled to in an inspection and what they are not entitled to. We read the tea leaves to understand when an inspection is going in a direction and intensity that is not expected. We know when to push back on FDA or just give them the information requested. We have experience with the investigators, the local district director, and the personnel in the Office of Compliance at the Center, in Silver Springs, Maryland.
  • Labels and labeling - We can help you understand the minutia of the regulations covering the label, labeling and advertising to make sure your product is compliant and does not run afoul of FDA.
  • Exports and import holds - We understand FDA's export regulations, especially when product is not yet approved in the U.S. and is headed for destinations outside the U.S. We can help you when U.S. Customs puts a hold or import alert on your product. We know when they are exceeding their jurisdiction and authority and how to get your goods into the U.S.
  • Negotiating with the FDA - We are constantly on the phone, sending emails, and meeting with FDA in person on behalf of clients. This familiarity breeds knowledge of how they think and operate from submissions to recalls, warning letters, and inspections. We can help you understand and work through your issues with the FDA at all levels.
Helping clients be appropriately aggressive, yet compliant.™