ADB Consulting & CRO Inc.
FDA medical device regulatory consulting with published flat-fee pricing. We prepare 510(k), De Novo, and Pre-Submission packages, perform QMSR/ISO 13485 and Section 524B cybersecurity gap assessments, and provide FDA establishment registration, device listing, and US Agent services for foreign manufacturers. Transparent fixed fees published at adbccro.com.
Founder & Principal Consultant: Andre Butler. Serving US-wide, remote. Published flat-fee services include: 510(k) Gap Assessment $4,950; 510(k) Pre-Submission tier $4,500; Full 510(k) Preparation from $24,500; FDA Pre-Submission (Q-Sub) Package $6,500; QMSR/ISO 13485 Gap Assessment Stage 1 (documentation) $3,495; QMSR/ISO 13485 Gap Assessment Stage 2 (records deep-dive) $6,995; Section 524B Cybersecurity Gap Assessment $3,495; 513(g) Classification Memo $1,495; 513(g) Submission $2,995; FDA Establishment Registration + Device Listing $795 (first device; +$95 each additional); UDI/GUDID Entry $395 per device; US Agent / Official Correspondent $595 per year; Registration + Listing + US Agent Bundle (Year 1, foreign establishments) $1,195; US Sponsor Readiness Assessment $4,500. IND Preparation & Submission is custom quoted. Also available: FDA 483 Response, AI/ML SaMD regulatory support, ISO 13485/QMSR quality systems, and IDE sponsor-of-record services (custom quoted). Phone: (888) 450-8607. Website: adbccro.com.
HQ:
Sunrise, Florida, United States
Claim status:
Claimed
Services & Capabilities
Find FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Industries:
Medical Devices
Response SLA:
hours
Pricing model:
Onboarding + annual retainer
Starting from:
USD 595
Included services:
US Agent / Official Correspondent - $595 per year, FDA Establishment Registration + Device Listing - $795 first device (+$95 each additional), UDI / GUDID Entry - $395 per device, Registration + Listing + US Agent Bundle Year 1 for foreign establishments - $1195
Product Type:
devices
Annual Renewal Support:
No
Registration Support:
Yes
Recall Support:
No
Inspection Support:
No
Emergency Contact24x7:
No
Annual Renewal Reminder:
No
510k_submission_services
Jurisdictions:
US
Countries:
US
Industries:
Medical Devices
Pricing model:
Per project
Starting from:
USD 1,495
Included services:
513(g) Classification Memo - $1495, 513(g) Submission - $2995, 510(k) Pre-Submission tier - $4500, US Sponsor Readiness Assessment - $4500, 510(k) Gap Assessment - $4950, FDA Pre-Submission (Q-Sub) Package - $6500, Full 510(k) Preparation - from $24500, IND Preparation and Submission - custom quoted
Services Offered:
Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, Pre-Sub / Q-Sub Preparation, Device Classification Support, 510(k) Strategy & Authoring, 510(k) eSTAR Preparation, Traditional 510(k) Support
Pathways Supported:
Traditional 510(k), De Novo, Pre-Sub / Q-Sub
Device Types Supported:
Medical device
Supports Estar:
Yes
Supports Rta Remediation:
No
Supports Predicate Research:
Yes
Supports Labeling Review:
No
Provides Submission Project Management:
No
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Accepting New Clients:
Yes
fda_qmsr_transition_inspection_readiness
Jurisdictions:
US
Countries:
US
Industries:
Medical Devices
Pricing model:
Per project
Starting from:
USD 3,495
Included services:
QMSR/ISO 13485 Gap Assessment Stage 1 (documentation) - $3495, QMSR/ISO 13485 Gap Assessment Stage 2 (records deep-dive) - $6995, Section 524B Cybersecurity Gap Assessment - $3495
Service Types:
QMSR/ISO 13485 Gap Assessment, 483 Response & Remediation Support
medical_device_cybersecurity
Countries:
US
Industries:
Medical Devices
Pricing model:
Per project
Starting from:
USD 3,495
Included services:
Section 524B Cybersecurity Gap Assessment - $3495
Pen Testing Available:
No
Threat Modeling Available:
No
Sbom Management Available:
No
Vulnerability Monitoring Available:
No
Rta Rescue Available:
No
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