We provide full lifecycle GMP compliance solutions covering system establishment, certification support, and continuous improvement to help enterprises meet domestic and international regulatory requirements, enhance quality management standards, and ensure product safety and market access.

1. International Certification Support：

Target Market Coverage：

·Western Markets：Assist with GMP inspections by US FDA, EU EMA, EDQM (CEP certification), and Australia TGA.

·Global Access: Support for WHO-PQ certification and GMP compliance in PIC/S member countries (e.g., Japan PMDA, Canada HPFB).

Service Offerings：

·Mock Audits: On-site pre-inspections and deficiency corrections based on target country regulations.

·Inspection Escort & Guidance: Experts provide full-process support during on-site inspections.

2. Domestic Certification Support：

1）NMPA Compliance：

·GMP compliance guidance for innovative/generic drug manufacturers undergoing inspections

·GMP system enhancement for APIs, excipients, and packaging materials prior to associated review

·Quality agreements and compliance bridging for MAH contract manufacturing

2）Compliance Services for International Companies in China：

Assisting overseas pharmaceutical manufacturers in passing NMPA foreign on-site GMP inspections

3. Supply Chain Compliance：

1）Supplier Management：

·Assist API, excipient, and packaging material manufacturers in passing audits by drug product clients or Qualified Persons (QPs)

·Review supplier quality agreements to ensure clear supply chain responsibilities (e.g., data integrity, change control)

2）Contract Manufacturing Compliance：

Bridge quality systems between MAHs and CMOs/CROs to ensure compliance with ICH Q7/Q10 requirements

4. System Audits & Assessments：

1）Comprehensive Gap Analysis：

·In-depth audits of facilities, equipment, documentation systems, and data integrity against China GMP, EU GMP, and ICH Q7/Q9/Q10 standards

·Specialized evaluations for sterile products, computerized systems, and biosafety (biological products)

2）Risk Assessment Reports：

Application of quality risk management tools (FMEA, HACCP) to identify critical control points and prioritized improvement recommendations

5. Remediation & Improvement：

1）CAPA Plan Development：

·Develop scientifically sound corrective and preventive actions (CAPA) for audit findings, ensuring root cause analysis and closed-loop management

·Assist companies in establishing CAPA tracking systems with periodic effectiveness verification

2）System Enhancement Services：

Quality culture training programs: GMP awareness, data integrity, deviation management, and change control workshops

6. Ongoing Compliance Support：

1）Annual Review & Maintenance: Conduct periodic GMP system audits to ensure continuous compliance with regulatory updates (e.g., FDA 21 CFR Part 211 revisions, EU GMP Annex amendments).

2）Regulatory Intelligence Monitoring: Provide alerts on critical market regulation changes (e.g., FDA warning letter trends, EU GMP Annex updates) with proactive adaptation guidance.

1. Global Expert Network:

Team includes former regulatory officials and multinational pharma quality executives with deep regulatory insights.

2. Multi-Dimensional Compliance Integration:

Combines GMP, GxP (GLP/GCP), data integrity (ALCOA+), and ESG (environmental & supply chain responsibility) requirements for integrated solutions.

3. Rapid Response & Cost Optimization:

Uses agile project management to shorten remediation cycles and risk-based approaches to minimize unnecessary resource expenditure.

4. Proven Track Record:

Supported 100+ companies in passing FDA/EU/NMPA inspections across chemicals, biologics, food (including dietary supplements), etc.

1. Chinese companies planning to enter international markets (APIs/drug products/biologicals/food).

2. Overseas pharmaceutical manufacturers requiring NMPA inspections.

3. Raw material, excipient, and packaging material producers facing supply chain audit pressures.

4. Marketing Authorization Holders (MAHs) and Contract Manufacturing Organizations (CMOs).