EAS Consulting Group
EAS Consulting Group – Expert FDA Regulatory Consulting for Medical Devices
EAS Consulting Group is a dedicated FDA regulatory consulting firm with 15 years of experience, specializing in supporting medical device companies. They offer comprehensive services including 510(k) submission authoring, regulatory pathway assessment, ISO 13485 Quality Management System consulting, FDA mock audits, inspection readiness, and ISO 14971 risk management.
About
**Who they are**
EAS Consulting Group provides expert FDA regulatory consulting for medical devices and other FDA-regulated products. They offer a holistic approach to product development and labeling, considering marketing objectives alongside the current regulatory landscape.
**Expertise & scope**
* Assistance with submissions for all FDA industry products and facilities, including GRAS, NDI, DMF, and IDEs.
* Comprehensive auditing services, from desk-reviews to mock FDA inspections and FSMA Readiness Assessments.
* Support for food safety certifications, including preparation, passing, and maintenance.
* Guidance on product development and labeling, addressing complex issues and regulatory processes at federal, state, and local levels.
* Remediation services for FDA Form 483 observations and Warning Letters, including CAPA development and execution.
* Expertise in food safety compliance for human and animal food companies, including GFSI, GMP, HACCP, and FDA/FSMA requirements.
**Reputation / proof points**
* Consultants include former FDA, USDA, and state investigators, laboratory personnel, and industry quality experts.
EAS Consulting Group provides expert FDA regulatory consulting for medical devices and other FDA-regulated products. They offer a holistic approach to product development and labeling, considering marketing objectives alongside the current regulatory landscape.
**Expertise & scope**
* Assistance with submissions for all FDA industry products and facilities, including GRAS, NDI, DMF, and IDEs.
* Comprehensive auditing services, from desk-reviews to mock FDA inspections and FSMA Readiness Assessments.
* Support for food safety certifications, including preparation, passing, and maintenance.
* Guidance on product development and labeling, addressing complex issues and regulatory processes at federal, state, and local levels.
* Remediation services for FDA Form 483 observations and Warning Letters, including CAPA development and execution.
* Expertise in food safety compliance for human and animal food companies, including GFSI, GMP, HACCP, and FDA/FSMA requirements.
**Reputation / proof points**
* Consultants include former FDA, USDA, and state investigators, laboratory personnel, and industry quality experts.
Additional information
EAS Consulting Group emphasizes a proactive approach to regulatory compliance, aiming to provide solutions that align with a company's marketing objectives while navigating complex federal, state, and local regulations. Their services are often delivered by small teams of expert consultants with diverse backgrounds. They guide clients through various regulatory processes, including government affairs strategies and policy change initiatives. For companies facing issues like increasing food recalls or needing to address FDA Form 483 observations, EAS offers strategic consulting and remediation plans to minimize risk and ensure compliance.
Key Highlights
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Provides expert FDA regulatory consulting for medical devices and other regulated products.
Source
“EAS Consulting Group – Expert FDA Regulatory Consulting for Medical Devices”
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Offers comprehensive support for FDA submissions across all product types and facilities.
Source
“EAS provides assistance with submissions for all FDA industry products and facilities.”
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Conducts thorough auditing services, including mock FDA inspections and FSMA readiness assessments.
Source
“EAS Consulting Group offers comprehensive auditing services, from desk-reviews of documents, policies, and procedures to in-depth mock-FDA inspections”
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Assists firms with responses to FDA Form 483 observations and Warning Letters.
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“EAS Consulting Group assists firms with preparation of responses to FDA in the event of a form 483 or Warning Letter”
Certifications & Trust Signals
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Consultants include former FDA, USDA, and state investigators, laboratory personnel, and industry quality experts.
Source
“EAS auditors are former FDA, USDA and state investigators, laboratory personnel and industry quality experts”
Buyer Snapshot
Best for
- Companies seeking expert guidance on FDA submissions.
- Firms needing assistance with product development and labeling compliance.
- Businesses requiring auditing and gap assessment services.
- Organizations responding to FDA 483 observations or Warning Letters.
How engagement typically works
- Collaborative, providing strategic consulting.
- Hands-on support throughout regulatory processes.
- Expert-led teams with complementary backgrounds.
Typical deliverables
- Regulatory strategy and guidance documents.
- Prepared and filed FDA submissions.
- Detailed audit reports with CAPA recommendations.
- Corrective action plans for FDA observations.
Good to know
- Best when proactive engagement is desired for product development and labeling.
- Ideal for companies needing to address specific FDA observations or compliance gaps.
HQ:
CA
Languages:
English
Timezones:
EST
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
510(k) Strategy & Authoring, Traditional 510(k) Support, Abbreviated 510(k) Support, Predicate Research & Substantial Equivalence Strategy, Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Abbreviated 510(k), Special 510(k)
Device Types Supported:
Medical device
Years Experience:
15
Num510k Submitted:
45
Ex FDA:
Yes
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
general_surgery, gastro_urology, orthopedic, neurology, cardiovascular
Accepting New Clients:
Yes
Supports Estar:
No
Supports Rta Remediation:
No
Supports Predicate Research:
Yes
Supports Labeling Review:
No
Provides Submission Project Management:
Yes
Engagement Models:
Consulting, Submissions, Auditing, Training, Legal Support
