J&J
J&J Compliance Consulting LLC
J&J – FDA 510(k) & Regulatory Consulting for Medical Devices
J&J is a dedicated FDA regulatory consultant with 10 years of experience, specializing in guiding medical device companies through complex regulatory pathways. They offer comprehensive expertise in regulatory compliance, quality management systems, risk management, and auditing.
About
**Who they are**
J&J Consulting Group is a regulatory compliance firm specializing in guiding medical devices and other life science products through complex regulatory landscapes. They focus on transforming regulatory challenges into business advantages for their clients.
**Expertise & scope**
* FDA 510(k) premarket notification process guidance.
* Demonstrating substantial equivalence to legally marketed devices.
* Translating product design, features, and testing data into FDA-compliant submissions.
* Ensuring submissions are clear, compliant, and compelling.
* Navigating regulatory compliance for medical devices, biotech, and other life science industries.
* Services extend to cosmetic products, dietary supplements, drugs and bioscience, food and beverage, and tobacco products.
* Expertise in cosmetic facility registration requirements, including the July 1, 2024 deadline under MoCRA.
* Guidance on clinical study planning and execution.
**Reputation / proof points**
* Located at 1101 California Ave Suite 100 Corona CA 92881.
J&J Consulting Group is a regulatory compliance firm specializing in guiding medical devices and other life science products through complex regulatory landscapes. They focus on transforming regulatory challenges into business advantages for their clients.
**Expertise & scope**
* FDA 510(k) premarket notification process guidance.
* Demonstrating substantial equivalence to legally marketed devices.
* Translating product design, features, and testing data into FDA-compliant submissions.
* Ensuring submissions are clear, compliant, and compelling.
* Navigating regulatory compliance for medical devices, biotech, and other life science industries.
* Services extend to cosmetic products, dietary supplements, drugs and bioscience, food and beverage, and tobacco products.
* Expertise in cosmetic facility registration requirements, including the July 1, 2024 deadline under MoCRA.
* Guidance on clinical study planning and execution.
**Reputation / proof points**
* Located at 1101 California Ave Suite 100 Corona CA 92881.
Additional information
J&J Consulting Group positions itself as an expert guide, akin to a sherpa for navigating the complex FDA 510(k) process. They emphasize the importance of a well-prepared submission to avoid costly delays and ensure a product's successful market entry. Their approach involves translating technical product information into the specific language and format required by the FDA, aiming for clarity and compliance to expedite the review process. They serve a broad range of industries beyond medical devices, including cosmetics, dietary supplements, drugs, food and beverage, and tobacco products, indicating a versatile regulatory compliance capability.
Key Highlights
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Specializes in guiding medical devices through the FDA's 510(k) premarket notification process.
Source
“Getting a medical device to market in the U.S. often means going through the FDA’s 510(k) premarket notification process.”
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Helps demonstrate substantial equivalence to legally marketed predicate devices.
Source
“At its core, a 510(k) consultant’s job is to steer your medical device through the FDA’s clearance process.”
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Serves a diverse range of industries including Medical Devices, Cosmetic Products, Dietary Supplements, Drugs and Bioscience, Food and Beverage, and Tobacco Products.
Source
“Industries served Cosmetic Products Dietary supplement”
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Provides guidance on cosmetic facility registration requirements, including the July 1, 2024 deadline.
Source
“Cosmetic facilities must register with the FDA by July 1, 2024.”
Certifications & Trust Signals
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Located in Corona, CA.
Source
“1101 California Ave Suite 100 Corona CA 92881”
Buyer Snapshot
Best for
- Companies seeking expert guidance through the FDA 510(k) process.
- Businesses needing to demonstrate substantial equivalence for their medical devices.
- Firms requiring assistance with regulatory compliance across various life science industries.
How engagement typically works
- Collaborative, acting as a 'regulatory sherpa'.
- Focus on translating technical data into compliant submissions.
- Proactive guidance to avoid common pitfalls.
Typical deliverables
- FDA 510(k) submission preparation.
- Regulatory strategy and guidance.
- Compliance documentation and review.
- Support for cosmetic facility registration.
Good to know
- Best when engaging early in the product development lifecycle to ensure compliance from the outset.
Pricing
Model:
Per project
Public range:
Publicly listed: $150 - $17,500
Notes:
Pricing varies based on project scope and complexity.
“Pricing: $150; $500,; $17,500”
HQ:
Corona, US
Languages:
English
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, 510(k) Strategy & Authoring, Predicate Research & Substantial Equivalence Strategy, Submission Project Management (end-to-end), Traditional 510(k) Support, Special 510(k) Support, Abbreviated 510(k) Support
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k), De Novo, PMA, Pre-Sub / Q-Sub
Device Types Supported:
Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
30
Num510k Submitted:
15
Ex FDA:
Yes
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
Medical Devices, Cosmetic Products, Dietary supplement, Drugs and Bioscience, Food and Beverage, Tobacco Products
Accepting New Clients:
Yes
Supports Estar:
No
Supports Labeling Review:
Yes
Provides Submission Project Management:
Yes
Engagement Models:
Project-based
Typical Lead Time Weeks:
18
Response Time Hours:
24
