As global pharmaceutical regulations become increasingly stringent, GxP compliance underpins the entire drug lifecycle — from R&D and manufacturing to distribution and post-market surveillance. For Marketing Authorization Holders (MAHs), manufacturers, R&D institutions, and distribution companies seeking access to China and other major markets, establishing a robust quality system aligned with GMP, GSP, GVP, and GCP requirements is essential.
BaiPharm offers integrated, customized GxP solutions on a consulting + auditing dual-track model across four core domains — GMP, GSP, GVP, and GCP — helping you mitigate risks, navigate inspections, and elevate your quality management capabilities.
Our Services
BaiPharm operates on a consulting + auditing dual-track model, delivering comprehensive GxP support across four core domains:
GMP Compliance Consulting (Good Manufacturing Practice)
Ensuring that every stage — from facility design to product release — meets GMP standards across China, the U.S., the EU, and WHO guidelines.
New Facility/Workshop Compliance Planning: Supporting projects from the design phase to ensure that both infrastructure and systems comply with GMP requirements.
Gap Analysis and System Enhancement: Conducting comprehensive evaluation of the existing quality management system, identifying gaps against target regulations, and offering actionable remediation plans.
Mock GMP Audits: Performing full-scale mock audits before official inspections to help enterprises familiarize themselves with regulatory expectations, identify potential risks, and enhance inspection readiness.
Document System Construction and Optimization: Assisting in the establishment and enhancement of a complete documentation system, from Standard Management Procedures (SMPs) to Standard Operating Procedures (SOPs).
Validation Consulting Services: Providing expert support in process validation, cleaning validation, analytical method validation, and computerized system validation.
Quality Risk Management and Co-line Production Evaluation: Providing scientifically grounded assessments and risk control strategies.
China GSP Compliance Consulting (Good Supply Practice)
Safeguarding pharmaceutical quality, safety, and traceability throughout the distribution chain — for wholesalers, retail chains, and modern logistics centers.
One-stop GSP compliance consulting for new enterprises.
Guidance for the construction and certification of modern pharmaceutical logistics centers.
Quality management system documentation optimization and personnel training.
Cold chain validation services: Conducting comprehensive temperature mapping and validation for warehouses, temperature-controlled containers, transportation vehicles, etc.
System integration services for single pharmacies into chain pharmacies.
Mock GSP inspections and deficiency rectification guidance.
China GVP Compliance Consulting (Good Pharmacovigilance Practice)
Establishing proactive drug safety monitoring systems to support MAHs in fulfilling their lifecycle safety responsibilities.
Building and Optimizing Pharmacovigilance Systems: Assisting in the establishment of organizational structures, systems, processes, and resource allocation in compliance with China GVP.
Individual Case Safety Report (ICSR) Management: Guiding or supporting the collection, verification, entry, and submission of SUSARs/ICSRs.
Periodic Safety Update Report (PSUR) Preparation and Submission.
Risk Management Plan (RMP)/Pharmacovigilance Plan Development.
Literature Search and Monitoring Services.
Safety Information Updates for Chinese Medicine Labels.
Pharmacovigilance Support for International Drug Exports (especially to the EU and US markets).
China GCP Compliance Consulting (Good Clinical Practice)
Ensuring the authenticity, completeness, and reliability of clinical trial data while safeguarding the rights of study participants.
Building clinical trial quality management systems (QMS).
China GCP compliance gap analysis and system enhancement.
Review of key clinical documents (protocols and informed consent forms, etc.).
Ethics Committee application support.
Selection and evaluation of research centers and investigators.
Clinical monitoring and audit support.
Consulting for investigational medicinal products / medical device management.
Data compliance management support.
Third-Party GxP Auditing Services
As an independent third party, BaiPharm provides objective and professional audits to help clients effectively manage supply chain and partner risks.
Audit Scope: Supplier Audits (raw material suppliers, excipient suppliers, packaging material suppliers, and critical ingredient suppliers).
Contractor Audits: Auditing MAHs' CMOs/CDMOs; auditing partners involved in pharmacovigilance, warehousing, transportation, sales, and other activities.
System Audits: Conducting comprehensive GMP, GSP, GVP, and GCP system audits.
Our Approach
BaiPharm follows a structured project methodology to ensure systematic and actionable compliance outcomes:
Needs Assessment: Gain a thorough understanding of your product profile, target markets, and current quality system status.
Gap Analysis: Identify critical gaps and risks relative to applicable regulations.
Solution Design: Develop a tailored remediation roadmap, including timelines and resource allocation.
Implementation Support: Assist with documentation updates, staff training, facility improvements, and mock inspections.
Ongoing Support: Support during official inspections and post-approval compliance maintenance.
Why Choose BaiPharm?
BaiPharm, a specialized subsidiary of REACH24H Consulting Group, is dedicated to pharmaceutical regulatory compliance. With offices in the U.S., EU, Japan, and South Korea, our expert team — including regulatory specialists, GxP auditors, consultants, certified toxicologists, and former inspectors — has supported over 600 pharmaceutical firms from 26 countries.
We help global and domestic pharmaceutical companies achieve robust, full-lifecycle GxP compliance with expert consulting, system optimization, validation, auditing and training. By proactively addressing regulatory gaps and preparing clients for inspections with mock audits, we ensure quality risks are controlled, regulatory approvals are secured, and compliance is maintained across China, the U.S., EU, and WHO markets.
In addition, we provide a specialized service supporting overseas companies in interpreting Chinese regulatory requirements and audit findings issued by Chinese authorities. Based on our regulatory expertise and practical experience, we translate inspection observations into clear, actionable remediation strategies, and provide tailored corrective and preventive action (CAPA) recommendations. We also assist clients in drafting and finalizing response letters and remediation reports, ensuring that submissions are aligned with regulatory expectations and effectively address identified compliance gaps.
Related REACH24H Resources and Services
Explore more BaiPharm pharmaceutical regulatory services:
Product Registration (NDA/BLA/ANDA)
Clinical Trial Applications (IND/CTA)
Domestic Responsible Person (DRP)
Pharmacovigilance (PV)
Toxicological Risk Assessment
Post-Marketing Compliance
Not sure where to start? Our regulatory experts are ready to help.
Email: customer@reach24h.com
