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Biotech & Pharmaceuticals
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US Agent for foreign companies
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Complex IND, NDA, and BLA application strategy
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CMC (Chemistry, Manufacturing, and Controls) compliance
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Orphan Drug Designation and Fast Track applications
Medical Devices
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US Agent for foreign manufacturers
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Premarket Strategy (510(k), De Novo, PMA)
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Quality System (QMS) Regulation 21 CFR Part 820 compliance
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Cybersecurity Submissions and Compliance
Food & Dietary Supplements
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US Agent & FDA facility registration
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Labeling review (FDA & USDA) and claim substantiation
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New Dietary Ingredient (NDI) notifications
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GRAS (Generally Recognized as Safe) determinations
Cosmetics & Personal Care
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MoCRA Registration and Product Listing
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Cosmetic labeling review and safety substantiation
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FDA Facility Registration (FEI Number)
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Good Manufacturing Practices (GMP) guidance
Digital Health & SaMD
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Pre-submission strategy for Software as a Medical Device (SaMD)
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Digital Health Pre-Cert (Pre-Cert) Program readiness
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Clinical Decision Support (CDS) Software evaluation
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AI/ML (Artificial Intelligence/Machine Learning) change management plans
Other Services
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General regulatory consulting and gap analysis
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FDA meeting preparation and representation
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Regulatory due diligence for mergers and acquisitions
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Post-market surveillance and reporting compliance
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Expert FDA Compliance Guidance
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Navigating FDA Approval and Registration
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How To Get DUNS Number For Free For FDA Registration
Navigating FDA registration requirements starts with obtaining your DUNS number—a critical identifier that costs nothing but can save your organization time and ensure compliance from day one. Understanding the DUNS Number Requirement for FDA Registration The Data Universal Numbering System (DUNS) number serves as a unique nine-digit identifier for businesses worldwide, issued by Dun &
February 1, 2026 -
How to get an NDC Number
How to Get an NDC Number The National Drug Code (NDC) is a unique identifier assigned to medications in the United States, serving as a universal product identifier for human drugs. Managed by the Food and Drug Administration (FDA), the NDC system helps streamline drug tracking, billing, and inventory management. Whether you are a manufacturer,
February 1, 2026 -
FDA News Roundup: Key Updates for Regulated Companies
Keeping up with FDA news is not optional if you manufacture, import, label, distribute, or market regulated products in the United States. A single guidance update can change what “complete” looks like for a submission, a new enforcement policy can shift inspection priorities, and a compliance date (like FSMA traceability) can drive major operational work.
February 1, 2026 -
The FDA Approval Process: What “Getting Certified” Actually Means
What Is the FDA Approval Process? The FDA approval process is a rigorous system designed to evaluate whether new drugs, medical devices, or other health-related products are safe and effective for public use. This process begins with extensive research and development stages before progressing through multiple phases of review. The goal is to ensure that
February 1, 2026