PHDS HEALTHCARE RESEARCH Co., Ltd.
Services and Solutions
Global standards and quality systems, one-stop drug discovery and preclinical research services and solutions.
Product Registration
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Clinical application filing affairs
Service Overview
Our clinical trial application services provide comprehensive support for pharmaceutical and medical device companies, ensuring that your products comply with regulatory requirements before, during, and after clinical research and market launch. Our professional team is dedicated to providing one-stop services from regulatory policy research to registration declaration, project management, ethical review, data management, and result reporting, enhancing the transparency and reproducibility of research, safeguarding public health, and promoting the development of the pharmaceutical industry.
Service Content
Regulatory Policy Research and Tracking
In-depth Research:In-depth research on domestic and international regulations and policies, such as China's 'Drug Registration Management Measures' and 'Regulations on the Supervision and Administration of Medical Devices', as well as relevant provisions from international bodies like the US FDA and EU EMA.
Timely Tracking:Timely tracking of changes in regulations and policies so that companies can adjust their registration strategies according to new requirements.
Registration Strategy Development
Product Feature Analysis:Develop reasonable registration strategies based on product characteristics, R&D stages, and regulatory requirements of the target market.
Special Review Pathways:For innovative drugs, consider whether to apply for priority review or breakthrough therapy designation to expedite the registration process.
Data Preparation and Writing
Data Collection and Organization:Collect, organize, and write various materials required for registration, including technical documents of the product, clinical trial data, quality control documents, instructions, etc.
Meeting Review Requirements:Ensure that the materials are accurate, complete, and standardized to meet the review requirements of regulatory agencies.
Registration Declaration and Communication
Submitting Registration Applications:Submit registration applications to regulatory agencies and maintain communication with reviewers to answer questions and supplement materials.
Strictly Following Procedures:During the declaration process, it is necessary to strictly follow the prescribed procedures and timelines to ensure the smooth progress of the declaration work.
Project Management and Coordination
Multi-Department Coordination:Clinical registration affairs often involve multiple departments such as R&D, production, clinical research, quality control, etc. Registration specialists need to coordinate resources from all parties to ensure that each link's work can be completed on time.
Supporting Registration Declaration:To support registration declaration work.
Ethical Review and Data Management.
Ethical Review:The ethics committee reviews the design, implementation, and risks of the study to ensure that the research meets ethical standards and regulations, protecting the rights and safety of participants.
Data Management Analysis:Involves data collection, storage, management, and analysis to ensure data accuracy and completeness while using professional data management systems and statistical analysis tools.
Result Reporting
Writing Submission Reports:Write and submit trial reports and related papers including key results, conclusions, discussions, etc.
Our Capabilities
Professional Knowledge:Our team consists of clinical trial regulatory experts, registration affairs specialists, and project management experts who have a deep understanding of the clinical trial application process and regulatory requirements.
Efficient Processes:We have optimized the clinical trial application process to quickly respond to and handle various application matters, shortening your product's time to market.
Successful Cases:We have numerous successful cases helping clients smoothly navigate through the clinical trial application process to obtain regulatory approval.
Customer Service:We provide one-on-one customer service to ensure that every question you have receives timely and professional answers.
Why Choose Us
One-Stop Service:'From regulatory policy research to result reporting, we provide one-stop services so you don't have to worry about the complex clinical trial application process.'
'Our team members possess a strong industry background and professional knowledge to provide you with precise consulting services.''Continuous Support': 'We not only help you complete clinical trial applications but also provide subsequent supervision and management services to ensure your products remain compliant.'
Cost-effectiveness: Through our professional services, you can avoid the loss of time and cost caused by insufficient data preparation or unfamiliar processes.
Continuous support: We not only help you complete your clinical trial application, but also provide follow-up supervision and management services to ensure that your products are always in compliance.
By choosing us, you will get a trusted partner to help your product pass the clinical trial application smoothly and efficiently.We look forward to working with you to create the future of the pharmaceutical 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