Verusfda
VerusFDA
VerusFDA specializes in 510(k) submission services, guiding medical device manufacturers through the FDA approval process. They offer expertise to ensure compliance and successful market entry.
VerusFDA is a dedicated provider of 510(k) submission services, designed to assist medical device companies in navigating the complex regulatory landscape of the U.S. Food and Drug Administration (FDA). Their core competency lies in preparing and submitting 510(k) premarket notifications, a critical step for devices that are not exempt from FDA review. VerusFDA's team of experts possesses in-depth knowledge of FDA regulations, guidance documents, and submission requirements, ensuring that all documentation is accurate, complete, and compliant. By partnering with VerusFDA, clients can expect a streamlined and efficient submission process. The company focuses on minimizing delays and maximizing the chances of a successful clearance, allowing manufacturers to bring their innovative medical devices to market faster. They offer comprehensive support, from initial strategy development to post-submission follow-up, making them a valuable resource for any medical device company seeking FDA approval.
About
**Who they are**
Verusfda is a firm specializing in FDA regulatory strategy and compliance, assisting medical device manufacturers in navigating the complex approval processes. They focus on accelerating market entry while ensuring programs remain defensible.
**Expertise & scope**
* Guidance on FDA acceleration mechanisms including Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review, and RMAT.
* Development of disciplined eligibility framing, meeting strategies, and evidence roadmaps.
* Expertise in ensuring the defensibility of surrogate or intermediate endpoints for accelerated approval.
* Strategic planning for confirmatory evidence and lifecycle obligations, including post-market commitments.
* Assessment of eligibility across various acceleration pathways.
* Endpoint strategy development (surrogate vs. clinical) and confirmatory evidence concepts.
* High-level risk assessment for CMC (Chemistry, Manufacturing, and Controls) and lifecycle management, including comparability and scaling.
* Support for drafting designation requests, detailing disease context, unmet need, and competitive advantages.
* Integration of evidence summaries (clinical, nonclinical, mechanistic) with risk framing.
* Assistance with submission packaging and follow-up responses.
* Support for MoCRA Cosmetics, SaMD/Digital Health, and QMS/Risk Management.
**Reputation / proof points**
* Offices located in Miami, FL; Boca Raton, FL; and Washington, D.C.
* Commitment to responding within 1 business day for inquiries.
Verusfda is a firm specializing in FDA regulatory strategy and compliance, assisting medical device manufacturers in navigating the complex approval processes. They focus on accelerating market entry while ensuring programs remain defensible.
**Expertise & scope**
* Guidance on FDA acceleration mechanisms including Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review, and RMAT.
* Development of disciplined eligibility framing, meeting strategies, and evidence roadmaps.
* Expertise in ensuring the defensibility of surrogate or intermediate endpoints for accelerated approval.
* Strategic planning for confirmatory evidence and lifecycle obligations, including post-market commitments.
* Assessment of eligibility across various acceleration pathways.
* Endpoint strategy development (surrogate vs. clinical) and confirmatory evidence concepts.
* High-level risk assessment for CMC (Chemistry, Manufacturing, and Controls) and lifecycle management, including comparability and scaling.
* Support for drafting designation requests, detailing disease context, unmet need, and competitive advantages.
* Integration of evidence summaries (clinical, nonclinical, mechanistic) with risk framing.
* Assistance with submission packaging and follow-up responses.
* Support for MoCRA Cosmetics, SaMD/Digital Health, and QMS/Risk Management.
**Reputation / proof points**
* Offices located in Miami, FL; Boca Raton, FL; and Washington, D.C.
* Commitment to responding within 1 business day for inquiries.
Additional information
Verusfda emphasizes that acceleration is a contract earned through strong rationale, credible endpoints, and a clear plan for confirmatory evidence and lifecycle obligations. Their approach aims to build a coherent strategy linking eligibility to evidence and regulatory commitments. They highlight that programs can stall due to indefensible surrogate endpoints, unscalable CMC, or vague meeting requests. Verusfda's services are designed to address these potential pitfalls by anticipating post-market commitments and ensuring programs withstand scrutiny. They assist sponsors in determining applicable acceleration mechanisms and the necessary evidence to secure them, while also considering CMC scalability and lifecycle risks.
Key Highlights
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Specializes in FDA acceleration mechanisms like Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review, and RMAT.
Source
“We help sponsors pursue FDA acceleration mechanisms (Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review, RMAT)”
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Provides strategic planning for confirmatory evidence and lifecycle obligations, including post-market commitments.
Source
“with disciplined eligibility framing, meeting strategy, and evidence roadmaps that anticipate post-market commitments”
-
Offers expertise in developing defensible endpoint strategies, distinguishing between surrogate and clinical endpoints.
Source
“Accelerated approval hinges on surrogate/intermediate endpoints with justification.”
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Assists with high-level risk assessment for CMC and lifecycle management, addressing scalability and comparability.
Source
“High-level CMC and lifecycle risk assessment (comparability, scale, commitments)”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Medical device manufacturers seeking expedited FDA approval pathways.
- Sponsors needing strategic guidance on eligibility and evidence for acceleration programs.
How engagement typically works
- Consultative strategy development.
- Submission support and packaging.
Typical deliverables
- Acceleration strategy sprints.
- Designation request packages.
- FDA meeting strategy and briefing packages.
- Lifecycle execution and commitments support.
Good to know
- Best when sponsors have a serious condition or high unmet need to justify acceleration.
Pricing
Model:
Per project
Public range:
Publicly listed: $12,000–$30,000
Notes:
Pricing is scope-dependent.
“Typical range: $12,000–$30,000 (scope-dependent)”
HQ:
United States
Languages:
English
Timezones:
EST
Status:
listed
Services & Capabilities
FDA 510(k) Submission Services
Services Offered:
510(k) Strategy & Authoring, Predicate Research & Substantial Equivalence Strategy, 510(k) eSTAR Preparation, Traditional 510(k) Support, Special 510(k) Support, Abbreviated 510(k) Support, 510(k) RTA Remediation / Refuse-to-Accept Fix
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k)
Supports Estar:
Yes
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Additional 510k_submission_services Details
Services Offered
510(k) Submission Services, MoCRA Cosmetics, SaMD / Digital Health, QMS / Risk Management, Designation Request Package, FDA Meeting Strategy, Lifecycle Execution & Commitments Support, Acceleration Strategy Sprint
Pathways Supported
Traditional 510(k), Special 510(k), Abbreviated 510(k), De Novo, PMA, Pre-Sub / Q-Sub, Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review, RMAT
