PHDS HEALTHCARE RESEARCH Co., Ltd.
Services and Solutions
Global standards and quality systems, one-stop drug discovery and preclinical research services and solutions.
GMP compliance consulting
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On-site inspection support
Domestic on-site inspection support
Service Overview
Our CRO company provides comprehensive domestic on-site inspection support services for pharmaceutical and medical device companies, ensuring that clients can smoothly pass the on-site inspections by the National Medical Products Administration, safeguarding the safety, efficacy, and quality controllability of drugs and medical devices.
Service Content
GMP Compliance Assessment
- Provide detailed interpretations of GMP-related regulations to ensure clients fully understand and comply with GMP standards.
- Assess production facilities, operational processes, quality control, etc., to ensure compliance with GMP requirements.
R&D Process Optimization and Data Management:
- Assist in optimizing drug R&D processes to ensure that R&D activities comply with GMP specifications.
- Ensure the integrity, accuracy, and traceability of R&D data to meet regulatory requirements.
3. On-site Inspection Preparation:
- Develop a detailed on-site inspection plan, including the scope, methods, and schedule of the inspection.
- Help prepare all necessary documents and records, including production records, quality control records, and validation documents.
4. On-site Inspection Execution:
- During the on-site inspection, our professionals will accompany your team to ensure the inspection proceeds smoothly.
- Provide immediate answers to questions and feedback to help resolve issues identified during the inspection.
5. Rectification and Follow-up:
- Based on the results of the on-site inspection, develop a rectification plan to ensure timely correction of identified issues.
- Supervise the implementation of rectification measures to ensure continued compliance with GMP requirements.
Overseas On-site Inspection Support
Service Overview
For overseas markets, our CRO company provides professional on-site inspection support to help enterprises comply with different countries' GMP requirements and regulatory standards.
Service Content
International GMP Compliance Assessment
- Provide detailed interpretations of international GMP regulations to ensure clients understand and comply with the GMP standards of target countries.
- Assess production facilities, operational processes, quality control, etc., to ensure compliance with the GMP requirements of target countries.
International Regulatory Consulting:Provide consulting services for drug and medical device regulatory regulations in target countries to help enterprises successfully enter international markets.
Overseas On-site Inspection Accompaniment:During overseas on-site inspections, our professionals will accompany your team to ensure the inspection proceeds smoothly.
Establishment of International Quality Management Systems:Help enterprises establish quality management systems that comply with international standards, such as ISO 13485.
Pre-inspection Training
Service Overview
Our CRO company provides comprehensive pre-inspection training services to help enterprise employees improve their understanding and execution capabilities regarding GMP specifications.
Service Content
GMP Training:Provide GMP training for employees to enhance their understanding and execution capabilities regarding GMP specifications.
Quality Management System Training:Help CROs establish and implement quality management systems that comply with ISO standards.
Research Design and Implementation Training:Help CROs master methods and techniques for research design and implementation.
Ethics and Compliance Training:Help CROs understand and comply with ethical and compliance requirements.
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Contact Information
Customer service hotline:
E-mail:customer@cnphds.com
Address: Building A, Ocean Express,66 Xia Guang Li, Dong San Huan North Road,Chaoyang district, Beijing, China
Mobile
Public Number
京公网安备11010502056452号