Professional Services Disclaimer and Limitation of Liability
1. Nature of Services and Professional Advice:
Axentra Global Pharma Compliance LLC provides specialized regulatory compliance and consulting services for foreign manufacturers and U.S. importers. Our services are based on the current U.S. Food and Drug Administration (FDA) regulations, guidelines, and industry best practices.
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No Legal or Medical Advice: The information provided on this website, in our proposals, or in any delivered documents (including FSVP Plans, GMP Checklists, and Strategy Reports) is for professional consulting guidance only. It does NOT constitute legal advice, medical advice, or veterinary advice. Clients are strongly advised to seek independent legal counsel for any legal matters.
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Limitation of Liability: Our liability is strictly limited to the fees paid for the specific service rendered. We are NOT liable for any indirect, incidental, consequential, or punitive damages, including without limitation, loss of business, detained shipments, FDA fines, product recalls, or loss of profits arising out of the use or reliance on our consulting services.
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Non-Guarantee of Outcomes: Axentra Global Pharma Compliance LLC does NOT guarantee regulatory approval, clearance, inspection success, or favorable outcomes from the FDA or any other regulatory body. The final decision on compliance, registration status, and product admissibility rests solely with the U.S. FDA.
2. Client Responsibility and Implementation:
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Client is Responsible for Implementation: Our service is limited to providing expert strategy, documentation, and communication facilitation. The Client retains sole responsibility for the execution, maintenance, and ongoing compliance of their quality system, manufacturing processes, and supplier verification activities.
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Accuracy of Information: The Client warrants that all data, records, and information provided to Axentra are complete, accurate, and truthful. Axentra relies on the accuracy of this information to perform its services and is not liable for errors or non-compliance resulting from inaccurate information provided by the Client.
U.S. Agent and Official Correspondent Disclosure
1. Role of U.S. Agent & Official Correspondent:
Our firm is designated to fulfill the roles of U.S. Agent and/or Official Correspondent for foreign establishments, as required by the FDA.
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Primary Function: To act as the official communication link between the FDA and the foreign establishment (receiving and forwarding official, routine, and emergency correspondence).
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Limitations: The designation of Axentra Global Pharma Compliance LLC as a U.S. Agent or Official Correspondent does not mean that Axentra assumes responsibility for the manufacturer's compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) or any implementing regulations. Liability for product safety, quality, and regulatory compliance remains entirely with the foreign manufacturer/owner.
2. Address Verification and Mail Protocol:
The address provided on this website and used for FDA registration is our official "Place of Business" for the purpose of fulfilling the U.S. Agent requirement.
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U.S. Place of Business: 1209 MOUNTAIN ROAD PL NE, STE N, ALBUQUERQUE, NM 87110
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Mail Handling: All mail is received and digitally processed by our registered service provider and is reviewed for legal and compliance urgency.