Talented Consultants
Our Team of
Seasoned FDA Compliance Experts
our services

Expert FDA Compliance Consulting and US Agent

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Your Strategic Partner

We go beyond compliance. Our business-minded approach aligns regulatory strategy with your commercial goals to accelerate your time to market

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Guaranteed Transparency

Cost-effective, fixed-fee pricing with no hidden costs. We believe in upfront honesty, so you can budget with confidence.

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Execution & Submission

Our experts manage the entire submission process, ensuring flawless preparation and timely filing of all necessary applications.

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Industries

Biotech & Pharmaceuticals
  • US Agent for foreign companies

  • Complex IND, NDA, and BLA application strategy

  • CMC (Chemistry, Manufacturing, and Controls) compliance

  • Orphan Drug Designation and Fast Track applications

Medical Devices
  • US Agent for foreign manufacturers

  • Premarket Strategy (510(k), De Novo, PMA)

  • Quality System (QMS) Regulation 21 CFR Part 820 compliance

  • Cybersecurity Submissions and Compliance

Food & Dietary Supplements
  • US Agent & FDA facility registration

  • Labeling review (FDA & USDA) and claim substantiation

  • New Dietary Ingredient (NDI) notifications

  • GRAS (Generally Recognized as Safe) determinations

Cosmetics & Personal Care
  • MoCRA Registration and Product Listing

  • Cosmetic labeling review and safety substantiation

  • FDA Facility Registration (FEI Number)

  • Good Manufacturing Practices (GMP) guidance

Digital Health & SaMD
  • Pre-submission strategy for Software as a Medical Device (SaMD)

  • Digital Health Pre-Cert (Pre-Cert) Program readiness

  • Clinical Decision Support (CDS) Software evaluation

  • AI/ML (Artificial Intelligence/Machine Learning) change management plans

Other Services
  • General regulatory consulting and gap analysis

  • FDA meeting preparation and representation

  • Regulatory due diligence for mergers and acquisitions

  • Post-market surveillance and reporting compliance

Ensuring Market Success,
Expert FDA Compliance Guidance

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Trusted Regulatory Advisor
Navigating FDA Approval and Registration

news

  • How to search FDA registration number

    When it comes to importing, distributing, or verifying the legitimacy of products regulated by the U.S. Food and Drug Administration (FDA), one common question arises: How do I search for an FDA Registration Number? The answer depends on the type of product in question. The FDA maintains searchable databases for some product categories, while others—like

    September 23, 2025