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Zia U. Status: Offline
Malakand, Pakistan
100% Job Success
Top Rated

Ph.D. Chemist | Regulatory | APIs | Drug Product | Cosmetic | Dietary

"Ph.D. Chemist & Regulatory Affairs Specialist" ★ Drug Substance ★ Drug Products ★ Cosmetic ★ Dietary Supplement 1. Drug Substance Regulatory Affairs - Drug Master File (DMF) Writing - API Supplier Sourcing - ICH Q7 & cGMP Compliance - Compliance Audits (API Manufacturing) - Gap Analysis & RTR Prevention - Global Market Approvals (API) - End-to-End Regulatory Support 2. Drug Product Regulatory Affairs - FDA Submissions (ANDA/NDA/IND) - EU/MHRA Submissions (Hybrid Applications) - eCTD Documentation (Modules 1-5) - Gap Analysis & RTR Prevention - End-to-End Regulatory Support 3. Cosmetic Product Regulatory Affairs - FDA MOCRA Compliance and FDA Cosmetic Registration - CPSR/PIF/SDS/COA Drafting - EU/UK Cosmetic Notification or Registration - Product Safety Assessments 4. Dietary Supplement Regulatory Affairs - FDA Dietary Supplement Compliance - Facility Registration - Structure Function Claim Notification or Registration - New Dietary Supplement - FSVP Plan Guideline 🌟 Shared Across All Categories 🥇 100% Submission Acceptance 🥇 95% On-Time Delivery 🥇 60% Cost Savings 🥇 Free Consultation & Strategy 🔬 Regulatory Affairs Expert | Pharma & Cosmetic Compliance | 7+ Years | 100% Success Rate 🏆 With 7+ years of specialized expertise, I’ve empowered companies to secure ✅ Regulatory strategies (FDA, EU, MHRA) while saving clients 💸 $1M+ in costs through streamlined compliance and 🚫 zero Refuse-to-Receipt (RTR) risks. ✅ 32+ cosmetic registration approvals (cosmetic product, FDA, EU, UK). Created cosmetic product safety reports (CPSR), product information files (PIF), safety data sheets (SDS), and certificates of analysis (COA). 🚀 What I Deliver 1. 🧪 Drug Substance Expertise Ensure seamless API compliance & DMF success: ✔️ DMF Writing & Review: Drafted 📑 30+ globally compliant Drug Master Files (USFDA, EU, ANVISA). ✔️ Gap Analysis: Fix deficiencies in existing DMFs to avoid regulatory delays. ✔️ 🔍 API Supplier Sourcing: Partner with 🌍 vetted global suppliers for high-quality APIs/excipients. ✔️ 🛠️ Compliance Audits: Conducted 12+ audits for API sites, ensuring ✅ 100% GMP adherence. 2. 📂 Drug Product Submissions (eCTD Modules 1-5) From lab to market approval: ✔️ ANDA/NDA/IND Submissions: Delivered 📤 25+ ANDAs (FDA) + 15+ EU/MHRA hybrid applications. ✔️ 📊 eCTD Documentation: Expertly compile Modules 1-5 (CMC, clinical, non-clinical data). ✔️ 🚫 RTR Prevention: Zero Refuse-to-Review cases via meticulous gap analysis. ✔️ 📝 FDA Forms: Accurately complete 356h, 2253, and compliance declarations. ✔️ 🏭 Facility Registration: Register manufacturing sites per FDA/EU guidelines. 3. 💄 Cosmetic Compliance (FDA MOCRA/EU/UK) Simplify global cosmetic market entry: ✔️ FDA MOCRA Compliance: Register firms/cosmetic products + Amazon Launch. ✔️ 🇪🇺 EU/UK Regulation: Register cosmetic products, prepare compliant Product Information Files (PIF), Safety Data Sheets (SDS), and Cosmetic Product Safety Reports (CPSR). 4. Dietary Supplement Compliance (FDA/EU/UK) Simplify global dietary supplement market entry: ✔️ FDA DSHEA Compliance: Register firms/dietary supplements + Amazon Launch. Dietary Supplements Health and Education Act (DSHEA) ✔️ Structure Function Claim Notification or New Dietary Ingredient Notification (NDI) 🌟 Why Clients Choose Me ✅ Zero RTRs: 100% submission acceptance through rigorous gap analysis. ✅ ⏰ 95% On-Time Delivery: Met deadlines for 40+ projects in the last 3 years. ✅ 💰 60% Cost Savings 🛡️ My Ironclad Guarantee ✔️ Results-Driven: Work 🆓 FREE until you’re 100% satisfied. ANDA submissions | eCTD publishing | FDA MOCRA compliance | Cosmetic registration FDA, EU and UK | CPSR, PIF, SDS and COA | DMF writing | API sourcing ✔️ 🔗 End-to-End Support: From API sourcing to final approval—I simplify every step. 📩 Let’s Launch Your Product Confidently! 👉 Next Steps: Click 💬 “Send a Message” to discuss your regulatory needs. Get a 🆓 FREE 15-minute consultation + tailored strategy. Launch faster, smarter, and ✅ 100% compliant. 🏆 100% Success Rate | 🕒 7+ Years Expertise | Your compliance partner for pharma & cosmetics—because every submission deserves to succeed. 🌟
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Project catalog 

Get started working with Zia quickly with these predefined projects.

Get started working with Zia quickly with these predefined projects.

You will get ghs safety data sheets or sds or msds

From $20
1 day delivery

You will get professional consultation for DMF compilation and eCTD submission

From $100
3 days delivery

You will get cosmetic labels reviewed for full FDA compliance

From $30
1 day delivery

You will get Regulatory Affairs Speciality for CTD Module 1/2/3/4 & 5 Compilation

From $1,000
10 days delivery

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