FDA Compliance
FDA Compliance is our expertise. Safeguard your business and uphold safety standards by ensuring your products meet FDA regulations through our expert FDA Compliance services. We navigate the complex landscape to protect your brand.
US FDA Compliance and Registration
Unlock the vast potential of the US market by ensuring your products comply with FDA regulations. FDA registration not only provides market access but also enhances your credibility, all while streamlining compliance monitoring with the Unique Facility Identifier (UFI).
- Gain access to the US market
- Ensure compliance for your products
- Enhance credibility with FDA registration
- Streamline monitoring through the Unique Facility Identifier (UFI)
US Agent Service
Our dedicated US agent service acts as your strategic partner, simplifying the complex world of FDA regulations. We expedite communication, provide legal guidance, and leverage our regulatory expertise to ensure your products meet the highest standards and thrive in the competitive US market.
- Partner with a dedicated US agent
- Expedite communication and documentation
- Receive legal guidance to stay in compliance
Import Detention Assisstance
FDA Import Detention Assistance is a service that helps importers and businesses navigate issues related to the detention of their imported products by the U.S. Food and Drug Administration (FDA).
- Expert help for FDA-detained products
- Address issues and provide necessary documentation
- Expedite product release with legal expertise
- Seek assistance for tailored solutions
Import Alert Petition
This system analyzes and aims to control the biological, chemical, and physical hazards from raw material procurement or production level to the finished product consumption level.
- Request to lift or modify FDA Import Alert
- Addresses product safety, quality, or compliance issues
- Includes details and corrective actions
- FDA reviews for compliance
Warning Letter And 483 Response
Our service provides access to experienced professionals who specialize in addressing FDA Warning Letters and Form 483 observations.
- Access FDA experts
- Address violations and show compliance commitment
- Handle observations, ensure compliance
- Prevent further actions
Inspection Assisstance
Our service provides expert guidance and support to navigate FDA inspections effectively.
- Professional assistance for FDA inspections
- Prepare, align, and assure compliance
- Assistance during inspections
- Organize and access essential documents
- Address observations and compliance issues
Recall Assisstance
Our Recall assistance service offers expertise and guidance to navigate FDA recalls effectively.
- Customized recall plans
- Ensure proper documentation and reporting
- Assist with FDA, customer, and stakeholder communication
- Manage recall logistics effectively
FCE And SID Filing
Ensure that your canned food imports are fully compliant with FDA regulations to avoid potential risks.
- Specialized in ensuring FDA compliance for canned food products
- Guidance on customs regulations and documentation requirements
- Accurate preparation and submission for FCE and SID filings specific to canned foods
Expert Witness
Our service provides access to experienced FDA experts who can serve as witnesses in legal proceedings related to FDA regulations, compliance, and product safety.
- Expert testimony and opinions for legal cases
- Expert analysis of FDA-related documents
- Simplify complex FDA issues in legal proceedings
FSMA Product Risk Assessment
Our service offers expert guidance and analysis to assess the regulatory and safety risks associated with FDA regulated products.
- Ensure products meet FDA regulations
- Analyze health and safety risks
- Expert review of safety and efficacy data