Provision Consulting Group, Inc.
★★★★★
5.0
/ 5
•
32 reviews
Provision FDA is a U.S. FDA regulatory consulting firm specializing in helping businesses, especially those outside the U.S., navigate FDA regulations for market entry and compliance. They offer services like product registration, US agent representation, and compliance advisory.
Provision FDA is a specialized U.S. FDA regulatory consulting firm dedicated to assisting companies, particularly those located internationally, in successfully entering and complying with the U.S. market. With over 11 years of experience, they offer a comprehensive suite of services including FDA registration status verification, acting as a U.S. Agent, and providing expert guidance on innovative products, medical devices, drugs, and food & beverages. They are recognized as an Amazon (USA) SPN Partner and focus on helping clients overcome regulatory hurdles. Their expertise extends to navigating complex regulations like MoCRA for cosmetics and ensuring compliance with Quality System Regulations (QSR) for medical device manufacturers. Provision FDA emphasizes direct consultant involvement to ensure client success in the U.S. market, offering tailored strategies for product registration, compliance, and market access to major U.S. retailers.
About
**Who they are**
Provision Consulting Group, Inc. is a US-based FDA regulatory compliance firm with over 11 years of experience, serving over 2,200 global clients across 25 countries.
**Expertise & scope**
* Specializes in helping businesses, particularly those outside the U.S., navigate FDA regulations for market entry and compliance.
* Offers services including product registration, US agent representation, and compliance advisory.
* Expertise spans medical devices, pharmaceuticals, cosmetics, dietary supplements, and biologics.
* Provides guidance on quality management systems (cGMP), clinical and non-clinical trials.
* Assists with issues such as warning letters and flags from online platforms like Amazon.
* Offers FDA registration status verification for products.
* Advises on innovative product categorization and regulatory pathways.
* Helps identify device classifications and corresponding regulatory pathways.
* Supports compliance for drug products through IND, NDA, or OTC pathways.
* Assists in developing and tailoring quality management systems (cGMP) to meet FDA 21 CFR 820, 210 & 211 requirements.
* Provides support related to the Modernization of Cosmetics Regulation Act (MoCRA), including guidance on mandatory cosmetic recalls.
* Addresses Quality System Regulation (QSR) violations for medical device manufacturers.
**Reputation / proof points**
* Served 2,200+ global clients across 25 countries.
* Completed 50,000+ successful projects.
* Recognized as an Amazon Service Provider Network (SPN) Partner for FDA Compliance.
Provision Consulting Group, Inc. is a US-based FDA regulatory compliance firm with over 11 years of experience, serving over 2,200 global clients across 25 countries.
**Expertise & scope**
* Specializes in helping businesses, particularly those outside the U.S., navigate FDA regulations for market entry and compliance.
* Offers services including product registration, US agent representation, and compliance advisory.
* Expertise spans medical devices, pharmaceuticals, cosmetics, dietary supplements, and biologics.
* Provides guidance on quality management systems (cGMP), clinical and non-clinical trials.
* Assists with issues such as warning letters and flags from online platforms like Amazon.
* Offers FDA registration status verification for products.
* Advises on innovative product categorization and regulatory pathways.
* Helps identify device classifications and corresponding regulatory pathways.
* Supports compliance for drug products through IND, NDA, or OTC pathways.
* Assists in developing and tailoring quality management systems (cGMP) to meet FDA 21 CFR 820, 210 & 211 requirements.
* Provides support related to the Modernization of Cosmetics Regulation Act (MoCRA), including guidance on mandatory cosmetic recalls.
* Addresses Quality System Regulation (QSR) violations for medical device manufacturers.
**Reputation / proof points**
* Served 2,200+ global clients across 25 countries.
* Completed 50,000+ successful projects.
* Recognized as an Amazon Service Provider Network (SPN) Partner for FDA Compliance.
Additional information
Provision Consulting Group, Inc. emphasizes a hands-on approach, with in-house consultants directly handling FDA projects to ensure effective supervision and management. They analyze issues from the U.S. FDA's perspective to provide accurate solutions. For businesses entering the U.S. market, understanding the correct classification of products, whether medical devices, drugs, or cosmetics, is crucial as it dictates the regulatory pathway. The firm's expertise in areas like cGMP and quality management systems is vital for manufacturers aiming to avoid common pitfalls such as QSR violations and warning letters. Their services extend to verifying product registration status, offering assurance for sellers and distributors.
Key Highlights
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Over 11 years of experience serving clients in medical devices, pharmaceuticals, cosmetics, retail, and e-commerce.
Source
“Over 11 years, we've served 2,200+ global clients across 25 countries in medical devices, pharmaceuticals, cosmetics, retail, and e-commerce.”
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Completed over 50,000 successful projects for global clients.
Source
“With 50,000+ successful projects, you just found your your one-stop consulting firm for all FDA needs.”
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Expertise in navigating FDA regulations for product registration, US agent representation, and compliance advisory.
Source
“They offer services like product registration, US agent representation, and compliance advisory.”
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Assists with compliance for various product types including medical devices, drugs, cosmetics, dietary supplements, and biologics.
Source
“our in-house consultants with ex-FDA and 35+ years experienced industry experts in cosmetics, medical devices, pharmaceuticals, dietary supplements, and biologics sectors”
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Provides FDA registration status verification services.
Source
“We offer a specialized service to verify the FDA registration status of products.”
Certifications & Trust Signals
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Recognized as an Amazon Service Provider Network (SPN) Partner for FDA Compliance.
Source
“Provision Consulting Group: Now an Amazon SPN Partner - FDA Compliance”
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Employs consultants with ex-FDA and 35+ years of industry experience.
Source
“our in-house consultants with ex-FDA and 35+ years experienced industry experts”
Buyer Snapshot
Best for
- Companies outside the U.S. seeking FDA market entry and compliance.
- Businesses needing assistance with product registration and US agent representation.
- Medical device, pharmaceutical, and cosmetic manufacturers requiring quality system support.
How engagement typically works
- Direct handling of projects by in-house consultants.
- Analysis from the U.S. FDA's perspective.
- Tailored strategies for product compliance.
Typical deliverables
- FDA registration status verification reports.
- US Agent representation services.
- Quality Management System (cGMP) development and tailoring.
- Regulatory pathway guidance for drugs and medical devices.
- Support for cosmetic compliance under MoCRA.
- Assistance with FDA warning letters and compliance issues.
Good to know
- Best when requiring specialized expertise in FDA regulations for market entry and ongoing compliance.
HQ:
Chino Hills, US
Languages:
English
Timezones:
UTC-8
Status:
listed
Services & Capabilities
Best FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Registration Support:
Yes
Product Type:
devices
Additional us_agent_fda Details
Product Types
Medical Devices, Pharmaceuticals, Cosmetics, Dietary Supplements, Biologics, Drug Products, Food & Beverages
Registration Support
Yes, FDA registration status verification and product registration.
Recall Support
Yes, guidance on mandatory cosmetic recalls under MoCRA.
Inspection Support
Implied through QSR violation support and warning letter assistance.
Emergency Contact24x7
Not explicitly stated.
US Entity State
California
