Are you ready for an FDA FSVP inspection? We can help!
Experienced FDA Consultants
Imports | Foods | Dietary Supplements
Cosmetics | Pharmaceuticals | Medical Devices
ASK ABOUT OUR FSVP SERVICES!
Welcome
Global Regulatory Affairs and Compliance, LLC provides regulatory compliance solutions to FDA-regulated industries worldwide!
In today's regulatory environment, compliance is key for your company's success.
We provide sound, expert consulting services you can trust.
What We Do
Service Fees
Foreign Supplier Verification Program (FSVP)
First supplier & product category - $1199
Each additional supplier & product category - $899
Each FSVP Renewal - $799
Contact us for FSVP Agent Service
Food Facility Registration
Biennial Registration - US facility - $199
Biennial Registration - Foreign facility - $399
US Agent Services - $299 annually
Certificate of Registration - $50
Label Reviews
(Food, Beverage, & Dietary Supplements)
FREE Assessment to identify FDA violations
Complete review for each label - $399
Contact us for multiple label review discount!
These are the most popular services we provide.
Contact us for other FDA regulatory needs.
US Agent Services
Foreign manufacturers must identify a verified United States Agent, who must reside in or maintain a place of business in the US, to vouch for their product entry into the US. This person must be listed during the FSVP registration process. Our consulting service include the following:
- Assist FDA in communications with the facility,
- Respond to questions concerning the facility’s imported products,
- Assist FDA in scheduling inspections, and
- Receive information/documents from FDA, if FDA is unable to contact the foreign establishment directly.
Label Reviews
Depending on the product, there are label requirements to market and sell in the U.S. The manufacturer, distributer, or importer must comply with regulations.
We offer consulting service includes label review services for foods, dietary supplements, pharmaceuticals, and medical devices. For example, we can review your food Nutritional Facts Panel, Principal Display Panel, and Information Panel. We can also review your dietary supplement Supplement Facts Panel and review for health/medical claims.
Regulatory Guidance Services
Some of the services we offer for your
food, dietary supplement, cosmetic, pharmaceutical, and medical device
FSVP
Mock Audits
GMP, GXP assistance
483, Warning Letter responses
Detention and Import Alert Assistance
FDA Audit readiness and guidance
Let us know how we can help you!
Detention or Import Alert Consultation
At GRAC, LLC, we provide solutions for importing products to the highly regulated U.S. market by helping new and existing manufacturers, distributors, importers and exporters of regulated products navigate the regulatory maze and successfully enter and stay in U.S. markets. Our consulting services include expertise in assisting you if your product has been detained or placed on Import Alert.
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About GRAC
Our Experience
We have over 40 years of combined experience!
Perla Ortiz-Sanchez, CEO, MBA, MSN, RN is a Quality Management regulatory affairs professional.
Carlos Ortiz, BS, US Air Force and US Army Veteran and former FDA Compliance Officer, is a PCQI, HACCP Certified, FSVP, pharmaceutical regulatory affairs consulting professional.
He has over 20 years of experience providing FDA regulatory guidance and consultations to foreign and domestic companies.
Our Approach
Our friendly and professional consulting service includes a comprehensive consultation using a goal-oriented and cost-effective approach to assist foreign and domestic companies comply with US FDA regulations.
Why Us?
Our experts and professionals at GRAC, LLC will work directly with you to meet your consulting and regulatory needs.
We have the skills, knowledge, and years of experience to ensure your products meet FDA regulatory requirements.
Contact GRAC, LLC anytime at:
e-mail: info@gracllc.com
phone: 770-713-3630
Copyright © 2022 Global Regulatory Affairs and Compliance LLC - All Rights Reserved.
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