FDA Certification

Ensure your products meet international safety and quality standards with FDA Certification. Gain market access and build consumer trust, especially for food, drugs, cosmetics, and medical devices.



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Documents & Filing | Compliance Support | 5-Day Approval | 48-Hour Renewal | Free Consultation


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Everything You Need to Know

Overview of FDA Certification

The FDA (U.S. Food and Drug Administration) certification is a globally recognized standard that validates the safety, efficacy, and compliance of products such as food, cosmetics, medical devices, and pharmaceuticals for entry into the U.S. market. Corporate Analytica provides end-to-end assistance in securing FDA registration and clearances tailored to your product category.

Advantages of FDA Certification

  • Authorizes sale in the U.S. and globally trusted markets
  • Boosts product credibility and consumer trust
  • Minimizes import rejections and customs delays
  • Ensures regulatory compliance and safety assurance
  • Enhances brand image and global competitiveness

Eligibility Criteria

  • Manufacturers, exporters, and sellers of applicable products
  • Facility must comply with FDA Current Good Manufacturing Practices (CGMP)
  • Designated U.S. agent for non-U.S. companies
  • Valid product labeling and packaging standards
  • Detailed technical dossier or formulation, where required

Documents Required

  • Company registration certificate
  • Product formulation or ingredient list
  • Manufacturing process and facility details
  • Product label and packaging artwork
  • U.S. agent letter of authorization (for foreign entities)
  • Test reports and safety assessments (as applicable)

Certification Process

  1. Step 1: Determine product category and regulatory path
  2. Step 2: Appoint a U.S. FDA agent (for non-U.S. companies)
  3. Step 3: Compile and verify documentation and labeling
  4. Step 4: Submit application or register facility with FDA
  5. Step 5: Pay FDA registration fee (if applicable)
  6. Step 6: Obtain FDA registration number or approval (based on product type)
  7. Step 7: Ongoing compliance and renewal as required

Why Choose Corporate Analytica?

  • Expertise in FDA regulations and product classifications
  • U.S. agent support and documentation handling
  • Full-service FDA registration and compliance solutions
  • Affordable and transparent pricing packages
  • Guidance for food, drug, cosmetic & device companies

Post‑Certification Compliance

  • Annual renewal of FDA registration
  • Proper product labeling and packaging updates
  • Adherence to CGMP standards and FDA inspections
  • Ongoing monitoring of regulatory changes
  • Prompt updates for any product modifications or recalls

Penalty for Non-Compliance

  • Operating without may attract heavy fines.
  • Non-renewal of license before expiry can lead to penalties.
  • False or misleading may result in legal action.
  • Severe violations can even lead to business closure.

Frequently Asked Questions (FDA Certification)

Q1. Is FDA certification mandatory for exports to the U.S.?

Yes, for most regulated products like food, cosmetics, and medical devices, FDA registration or certification is mandatory to sell or distribute in the U.S.

Q2. How long does the FDA certification process take?

The timeline varies by product type, but basic registration typically takes 1–2 weeks, while approval for drugs or devices may take several months.

Q3. Do I need a U.S. agent for FDA registration?

Yes, all foreign companies must appoint a U.S.-based agent to act as a liaison with the FDA for communication and compliance.

Q4. What happens if my product is not FDA compliant?

Non-compliant products may be detained or rejected at U.S. ports and may also result in penalties or import alerts. Ensuring compliance is critical for seamless entry.

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