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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Establishment of R&D Quality System
Service Content
Customized GMP Compliance Consulting:Provide interpretation of GMP regulations and policies tailored to the R&D process, and customized training to ensure the R&D team deeply understands and complies with global GMP standards.
R&D System Compliance Audit:Conduct a comprehensive review of the R&D process and quality management system, identify and address potential compliance risks, ensuring that R&D activities meet GMP requirements.
Establishment and Optimization of R&D Quality System:Assist enterprises in establishing or optimizing a GMP-compliant R&D quality management system, including formulating quality policies, objectives, and drafting quality manuals, procedural documents, standard operating procedures (SOPs), etc.
Validation of R&D Facilities and Equipment:Conduct compliance assessments of the layout of R&D facilities and equipment, and guide the validation work to ensure that the R&D environment and equipment meet GMP requirements.
Compliance Guidance for R&D Processes:Review R&D process flows and operating specifications, provide optimization suggestions, ensuring that the R&D process strictly adheres to GMP requirements.
Management of R&D Document Records:Help enterprises develop and manage GMP-compliant R&D documents, including SOPs, batch records, quality control records, etc., ensuring the authenticity, accuracy, completeness, and traceability of documents and records.
R&D Risk Management:Identify and assess compliance risks in the R&D process, and develop corresponding mitigation strategies such as deviation management and corrective preventive actions.
Management of R&D Suppliers:Assist enterprises in establishing supplier evaluation, selection, auditing, and management systems to ensure that products provided by suppliers meet quality standards and GMP requirements.
Internal Audit and Rectification:Conduct regular internal audits to check the operation of the quality management system, provide rectification opinions and suggestions, and track the implementation of rectifications.
Crisis Response:Provide professional crisis response and solutions when compliance issues arise.
Our Strengths
Professional Team in the Industry:
Our team consists of GMP experts with a strong background in the pharmaceutical and medical device industries. They are not only proficient in regulations but also able to combine theory with practice to provide clients with practical solutions.
Excellent Project Execution Capability:
We have a successful project execution record, able to respond quickly to client needs, efficiently advance projects, ensuring complex quality system establishment tasks are completed within tight timeframes.
Innovative Solutions:
We continuously explore and develop new tools and methods to solve complex issues in the R&D quality system innovatively, maintaining forward-looking service and competitiveness.
Customized Client Services:
We understand that each client's needs are unique; therefore, we offer customized services to ensure our solutions precisely match clients' specific needs and challenges.
Continuous Technical Support:
We provide ongoing technical support and consulting services to help clients adapt to the ever-changing regulatory environment, ensuring their quality systems remain up-to-date.
Why Choose Us
Professional Compliance Assurance:
By choosing us, you will gain a partner with deep expertise and rich experience in GMP compliance. We can help your enterprise avoid potential risks and losses due to non-compliance.
Enhancing R&D Efficiency and Quality:
Our services aim to improve R&D efficiency by optimizing processes and quality management systems while ensuring product quality and enhancing market competitiveness.
Customized Solutions:
The customized solutions we provide ensure that your R&D quality system aligns perfectly with your business strategy and goals for optimal business outcomes.
Continuous Partnership:
We are not just service providers; we are your long-term partners. We are committed to building long-term cooperative relationships with clients for mutual growth and progress.
By choosing us, you will gain a comprehensive, professional, reliable partner for establishing your R&D quality system. 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.
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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
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Public Number
京公网安备11010502056452号