Services For Your Success
FDA AdvocacyRepresenting you at the FDA
Our great relationships at FDA do not get in the way of our advocacy. If you need representation during an FDA meeting, we are there for you. We know how to work with FDA diplomatically and respectfully.
FDA Advocacy
Our great relationships at FDA do not get in the way of our advocacy. If you need representation during an FDA meeting, we are there for you. We know how to work with FDA diplomatically and respectfully. We appreciate the job which FDA must do, and most of the time they are very good at it. We also recognize that FDA often does not strictly follow the "rules" which should govern their conduct and decision-making, and sometimes they need to be challenged. We enjoy our relationships with FDA, but our relationships never get in the way of advocating for our client’s position, to ensure that our clients get the best and most expeditious result possible. We are good at negotiating 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 also involved with enforcement outside of FDA. We also negotiate with the Office of Inspector General (OIG), the Department of Justice (DOJ) and United States Attorneys on investigatory matters and settlements
Regulatory ServicesWe help you identify and address problem areas: from compliance programs to due diligence.
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.
Regulatory Services
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 Regulatory Assignments Include
We provide a wide array of Regulatory servicesDevelopment Team Support
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.
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.
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.
Clinical Trial Agreements
Clinical trial agreements (CTAs) and other research-related agreements - We prepare and negotiate agreements related to the conduct of clinical trials, including CTAs, investigator agreements, investigator-initiated research grants, confidentiality agreements, hospital use agreements, and research consulting agreements.
Pre-Clinical/Clinical Services
The Right Data, The Right Way
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.
Routine Assignments Include
We provide a wide array of Pre-Clinical/Clinical servicesClinical Trial Agreements
Clinical trial agreements (CTAs) and other research-related agreements - We prepare and negotiate agreements related to the conduct of clinical trials, including CTAs, investigator agreements, investigator-initiated research grants, confidentiality agreements, hospital use agreements, and research consulting agreements.
Informed Consents
nformed consents - We prepare and negotiate informed consent documents to be 21 CFR Part 50 compliant, as well as to maintain consistency with the protocol and CTA.
Trial Design
We are not experts in trial design per se, but our vast experience negotiating with FDA in Pre-IDE, Pre-IND, and Pre-Sub meetings allows us to inform you what FDA will be thinking when it comes to issues like randomization and comparators (e.g. competitive device or historical control, etc.), elimination of bias, inclusion and exclusion criteria, length of follow-up, sample size, etc.
GCP and Related Compliance
We provide guidance on the laws and regulations for sponsors of clinical trials, including consenting, monitoring, documentation, financial disclosure, subject data privacy, and HIPAA.
Training
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.
Contract Research Organization (CRO) Assistance
We are a resource for legal services and counsel to CROs conducting clinical trials on behalf of sponsors.
