Organization
ADB Consulting & CRO Inc. is organized into practice groups. Each group is led by a practice director who is named in the statement of work and accountable for the engagement from kickoff to FDA decision. Additional regulatory, clinical, and quality staff are assigned by agreement and named in the SOW. Clients always know who is doing the work and who is responsible for it.
By Regulatory Function
Four practice groups cover the full regulatory, clinical, and quality lifecycle of a device program.
510(k), De Novo, PMA, 513(g), and Pre-Submission strategy and preparation, from predicate analysis through FDA clearance.
Explore the Regulatory Submissions practiceIDE strategy, U.S. Sponsor of Record responsibilities, early feasibility studies, and Breakthrough Device requests.
Explore the Clinical & IDE practiceQMSR and ISO 13485 gap assessments, FDA 483 and Warning Letter response, and procedure/records audits.
Explore the Quality & Compliance practiceAI/ML-enabled SaMD submissions, Predetermined Change Control Plans, and Section 524B cybersecurity documentation.
Explore the Digital Health & Cybersecurity practiceBy Device Area
Three device areas have dedicated pages because ADB's practices have the deepest history there.
Transcatheter structural heart, cardiac rhythm management, lead management, and cardiovascular software.
Explore Cardiovascular & Cardiac RhythmReusable and single-use surgical instruments, orthopedic implants, ENT devices, dental handpieces, and infusion sets.
Explore Surgical, Orthopedic & ENTSoftware as a medical device, AI/ML-enabled devices, clinical decision support, and connected devices under Section 524B.
Explore Digital Health & SaMDBeyond the Three Deep Pages
ADB supports device programs across the following categories. Each is delivered by a practice director together with regulatory, clinical, and quality staff, and where a program calls for device-area depth ADB does not carry in-house, ADB engages a domain specialist with that experience and names them in the SOW.
If your device category isn't one of the three with its own deep page, that doesn't mean ADB hasn't supported it — it means the category doesn't yet have a named device-area lead and a dedicated page of its own. The practice group handling your device type still applies the same senior-director staffing model described below; a deep page gets added once a practice has a named lead with sustained history in that area.
For Non-U.S. Manufacturers
For manufacturers outside the United States, ADB serves as U.S. Agent, official correspondent, and where required U.S. Sponsor of Record, so FDA has a U.S. counterpart and the sponsor has a single accountable team. Most of ADB's international sponsors have come from South Korea, Israel, India, and the United Kingdom; the program is open to manufacturers from any country.
Explore the International Sponsor ProgramGet Started
Tell us about your device and we'll route you to the right practice group — no sales pitch, no obligation.