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Over mij
FDA Regulatory & OTC Compliance Specialist with extensive experience guiding pharma, cosmetic, and wellness brands through US market entry.
Core Expertise:
• OTC Drug Monograph Compliance & Reformulation
• Drug Facts Labeling Audits (21 CFR 201.66)
• FDA Facility Registration (FEI/DUNS) & SPL Listing
• cGMP (21 CFR 211) & Warning Letter Risk Mitigation
I turn complex FDA standards into clear, actionable compliance roadmaps to protect your brand and accelerate your launch.... Lees meer