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Home > Pharmaceutical Registration and Compliance Consulting

Pharmaceutical Registration and Compliance Consulting

BaiPharm, a wholly owned subsidiary of REACH24H, provides comprehensive pharmaceutical regulatory consulting and technical services for a broad range of pharmaceutical-related products, including intermediates, APIs, excipients, packaging materials, and finished dosage forms. Our integrated service portfolio includes product registration, pharmacovigilance, Domestic Responsible Person (DRP) services for overseas MAHs, GxP compliance, regulatory intelligence, and toxicological risk assessment.

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Our Services

Product Registration

China DMF Filing for APIs, Excipients and Packaging Materials Post-Marketing Compliance: Annual Reports, Variation & Renewal China Clinical Trial Applications (IND/CTA) China Drug Marketing Authorization Applications (NDA/BLA/ANDA) China ANDA Registration for Generic Drugs

Pharmacovigilance

Pharmacovigilance

DRP of Overseas MAH

Domestic Responsible Person (DRP) of Overseas MAH

GxP Compliance Consulting

GxP Compliance: Consulting, Auditing & Beyond

Other Services

Market Access Strategy Local Agency Support Customized Training & Webinars Medical Translation Service

Experience & Advantages

Proven Technical Expertise

Outstanding Global Service Network

Success Studies

BaiPharm Assists China-Based Innovators in Successful U.S. FDA Type II DMF Filing

BaiPharm Assists China-Based Innovators in Successful U.S. FDA Type II DMF Filing

BaiPharm Supports Successful U.S. FDA DMF Filing for Chinese Exosome Innovator

BaiPharm Supports Successful U.S. FDA DMF Filing for Chinese Exosome Innovator

New Beginnings, New Horizons: A Strategic Merger for Enhanced Pharmaceutical Solutions

New Beginnings, New Horizons: A Strategic Merger for Enhanced Pharmaceutical Solutions

News & Insights View More

Navigating China's 30-Day IND Fast Track: A Strategic Guide for Overseas Drug Developers

Pharmaceutical

Navigating China's 30-Day IND Fast Track: A Strategic Guide for Overseas Drug Developers

NMPA Data Exclusivity 2026: Chemical Drug Protection Guide

Pharmaceutical

NMPA Data Exclusivity 2026: Chemical Drug Protection Guide

2025 Regulatory Insights: Navigating Pharmaceuticals Regulations in China

Pharmaceutical

2025 Regulatory Insights: Navigating Pharmaceuticals Regulations in China

China Unveils Fifth List of Pediatric Drugs Promoting R&D

Pharmaceutical

China Unveils Fifth List of Pediatric Drugs Promoting R&D

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Everything You Need to Know about Canadian Natural Health Products Regulations

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Industrial Chemical Agrochemical Disinfectant & Biocide Food Contact Material & Recycled Plastic Food Cosmetic Pharmaceutical

Product Registration and Compliance Consulting Sustainability Solutions Global Market Access Solutions Regulatory Alerts and Market Intelligence

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