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PHDS HEALTHCARE RESEARCH Co., Ltd. (CRO) is a CRO company serving the world, a national high-tech enterprise, and one of the leading contract research institutions (Contract Research Organization) in the industry.

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Global standards and quality systems, one-stop drug discovery and preclinical research services and solutions.

GMP compliance consulting

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Third-party GxP audit


Service Content

Comprehensive GxP Audit Services

Provide comprehensive GxP (Good Practice) audit services, covering GMP (Good Manufacturing Practice), GCP (Good Clinical Practice), and GLP (Good Laboratory Practice), ensuring that enterprises comply with industry standards at all stages.   
Customized Audit Plan   
Customize the audit plan according to the specific needs of the enterprise and product characteristics, ensuring the relevance and effectiveness of the audit process.   
Audit Team Dispatch   
Dispatch experienced audit teams with deep GxP knowledge and industry experience, capable of accurately identifying and assessing potential compliance risks.

Detailed Audit Report    
Provide detailed audit reports, including audit findings, risk assessments, and improvement suggestions, helping enterprises understand their compliance status and take appropriate measures.   
Risk Assessment and Management   
Identify key risk points and provide risk management strategies to help enterprises reduce compliance risks and improve operational efficiency.   
Regulatory Updates and Training   
Provide information on new GxP regulatory updates, adjust audit focus according to regulatory changes, and offer necessary training to ensure that enterprise teams have a thorough understanding of GxP requirements.
Post-Audit Rectification Support 
Provide rectification support after the audit, including formulating rectification plans, monitoring rectification progress, and ensuring that rectification measures are effectively implemented. 
Continuous Compliance Monitoring 
Provide continuous compliance monitoring services, conducting follow-up audits regularly to ensure that the enterprise's GxP compliance status is maintained continuously.
Crisis Response and Support   
Provide crisis response strategies and support when serious compliance issues are discovered, helping enterprises respond quickly and resolve problems. 
International Audit Services 
Provide international audit services to help enterprises comply with GxP requirements in different countries and regions, supporting their global development.

 

Our Strengths

Cross-Disciplinary Professional Experience

Our team members have cross-disciplinary professional experience covering multiple industries such as pharmaceuticals, medical devices, clinical research, and health products.
Efficient Audit Process
We adopt an efficient audit process that can quickly complete audit tasks without affecting the normal operation of the enterprise.
Client-Customized Services
We understand that each client's needs are unique; therefore, we provide customized audit services to ensure our solutions precisely match the specific needs and challenges of our clients.
Continuous Technical Support
We provide ongoing technical support and consulting services to help clients adapt to the ever-changing regulatory environment, ensuring their compliance systems remain up-to-date.

 

Why Choose Us

Reduce Compliance Risks
Our audit services help enterprises identify and resolve compliance issues in a timely manner, reducing legal and financial risks associated with violations.
Improve Operational Efficiency
Our audit services not only help enterprises comply with GxP requirements but also optimize processes to improve operational efficiency and reduce costs.
Support Global Expansion
Our international audit services support enterprises' compliance on a global scale, helping them successfully enter new markets.
Continuous Partnership
We are not just an audit service provider; we are your long-term partner. We

are committed to establishing long-term cooperative relationships with clients for mutual growth and progress.

 

 

 

By choosing us, you will gain a comprehensive, professional, reliable third-party GxP audit partner. Our services will help your enterprise maintain a high-quality position in the market, ensure compliance, enhance efficiency, and achieve sustainable development. We look forward to collaborating with you to create new heights in the industry.