Zia U.

Global Regulatory Affairs & Compliance Consultant | FDA, EMA, MHRA | Pharmaceuticals, Cosmetics, OTC & Dietary Supplements Bringing a product to market is challenging. Regulatory delays, deficient submissions, non-compliant labels, or failed audits can cost companies months of lost revenue and significant remediation expenses. I help pharmaceutical, cosmetic, OTC drug, dietary supplement, and medical device companies navigate global regulatory requirements with confidence. I am a PhD Chemist with 9+ years of Regulatory Affairs experience supporting manufacturers, brand owners, distributors, and investors across the United States, European Union, and United Kingdom. My expertise spans regulatory strategy, dossier preparation, compliance audits, market authorization, and post-approval lifecycle management. Regulatory Experience ✔ 8+ ANDAs successfully delivered ✔ 15+ EU & MHRA Hybrid Applications supported ✔ 100+ Drug Master Files (DMFs) prepared, reviewed, or remediated ✔ 18+ API compliance audits conducted in accordance with ICH Q7 ✔ 200+ cosmetic brands supported for FDA MoCRA, EU CPNP, and UK SCPN compliance ✔ 100+ OTC drug listings and NDC registrations completed ✔ 100+ dietary supplement and consumer health products launched successfully Areas of Expertise Pharmaceuticals • ANDA, IND, NDA, MAA, and Hybrid Applications • eCTD Publishing and CTD Modules 1–5 • CMC Documentation and Regulatory Strategy • Drug Master Files (DMF) • Deficiency Letter and RTR Response Support • GMP and Inspection Readiness • Regulatory Gap Assessments APIs & Excipients • ICH Q7 Compliance Audits • Supplier Qualification Programs • Quality Agreements • DMF Development and Remediation • Technical Documentation Reviews Cosmetics (US, EU & UK) • FDA MoCRA Compliance • Cosmetic Product Safety Reports (CPSR) • Product Information Files (PIF) • CPNP & SCPN Notifications • Ingredient Compliance Reviews • Labeling & Claims Compliance • Safety Data Sheets (SDS) Dietary Supplements & Consumer Health Products • FDA Compliance Reviews • Structure/Function Claim Reviews • Label Compliance • NDI Assessments • Ingredient Safety Evaluations • Facility Registration Support Medical Devices • Regulatory Strategy • Technical Documentation Reviews • FDA Registration & Listing Support • Quality System Compliance Compliance & Quality Support • GMP & GDP Compliance • Internal Audits • Supplier Audits • CAPA Systems • Change Control Programs • Risk Assessments • Regulatory Intelligence • SOP Development • Quality Management Systems Why Clients Hire Me I focus on preventing regulatory issues before they become costly business problems. Whether you need a submission-ready dossier, a compliant cosmetic launch, an FDA label review, a DMF remediation project, or an audit-ready quality system, I provide practical regulatory solutions aligned with current FDA, EMA, MHRA, and international requirements. My goal is simple: help clients achieve faster approvals, maintain compliance, and reduce regulatory risk. Let's discuss your project and identify the most efficient regulatory pathway for your product.