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Introduction to Drug Registration
The registration team of DiQi Pharma is committed to accelerating the development and launch of pharmaceutical and health products, benefiting the vast number of patients. We can provide registration and consulting services covering the entire lifecycle of pharmaceutical products, including chemical drugs, high-end excipients, and biopharmaceuticals, medical devices, and health foods. Our registration services cover China, the United States, the European Union, as well as major countries and regions around the world. Our registration affairs experts have over 30 years of experience in registration management, with a strong pharmaceutical background and high-quality internal control processes. They have a deep understanding of the constantly changing regulatory environment in the local area and maintain good communication with regulatory authorities. This enables us to choose the right development path and appropriate registration strategy, submit application materials that meet regulatory requirements and product characteristics, and ensure smooth and efficient product registration.
Among the products developed or commissioned by DiQi, there are 4 products that have been approved for market by the US FDA; 4 FDA clinical approvals; 6 FDA DMF registrations for excipients; 4 domestic clinical approvals; 18 supplementary applications for consistency evaluation have been approved; There are 6 auxiliary material registrations, 2 CDE consistency evaluation products under review, and 5 generic drug products. Advantages of DiQi:
- Provide synchronous evaluation, planning, feasibility consultation, and pharmaceutical related advice in key CMC R&D activities;
- Ensure that high-quality source documents are prepared in advance for application submission;
- Ensure the submission of high-level application materials to improve the speed of evaluation;
- Provide suggestions and relevant support that comply with regulatory requirements;
- Translation services between Chinese and English for different application requirements;
- Mature and efficient eCTD electronic declaration service
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Drug registration service
The registration services provided by DiQi Pharma include:
Registration consultation
- Product development and registration consultant;
- Feasibility assessment of registration;
- Registration strategy and plan development;
Medical product registration (including NPMA, FDA, etc.)
- Writing of application materials and analysis of material defects
- Integration and release of application materials (including eCTD)
- Register agent
- Clinical trial application (Pre IND, IND, etc.)
- Listing application (Pre NDA, NDA, BLA, ANDA, etc.)
- DMF registration (active pharmaceutical ingredients, pharmaceutical excipients, pharmaceutical packaging materials, etc.)
- Registration Certificate Maintenance
- Supplementary application
- Orphan Drug Identification
- Accelerate approval of applications
- Breakthrough therapy recognition
- Clinical trials of pediatric drugs
- Scientific advice application
- Annual Report
- Clinical trial registration
- BE filing
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Quality management system
Since its establishment, the company has been committed to establishing a quality system for drug research and development, referring to the GMP management concepts at home and abroad, to control the entire process of drug research and development, with the goal of creating a first-class quality management system for drug formulation research and development. The company has a quality department that adopts controlled management from the initiation of research and development projects to the distribution and archiving of experimental record books, project document review and approval, stability testing, and other aspects; All drug analysis instruments are calibrated and confirmed to ensure the accuracy and correctness of experimental data; The R&D experimental process and instrument usage are fully documented and meet traceability requirements; All materials, standard substances, samples, etc. used in research experiments are subject to source verification and standardized storage and use; Deviations and changes in the drug development process CAPA、OOS/OOT、 Manage quality assurance elements such as risk assessment and establish a compliant and scientific quality management system.
Dr. Tang-sheng Peng, the head of quality management at the company, has over 20 years of experience in US pharmaceutical administration, quality control, and drug analysis. He has served as the Director of Analysis, Vice President of Quality, and Director of Drug Administration at several pharmaceutical companies, and has extensive experience in FDA and EU certification.
The company has been awarded the title of "Guangdong Province Generic Drug Quality Consistency Evaluation Research Engineering Center" by the Guangdong Provincial Department of Science and Technology, and has repeatedly passed on-site inspections, third-party inspections, and customer quality audits by national and provincial drug regulatory authorities, receiving unanimous praise.
The company has established a clinical trial preparation workshop that meets the D-level cleanliness requirements, and has established a corresponding GMP management system to ensure that the workshop minimizes the risks of contamination, cross contamination, confusion, errors, etc. in the drug production process, and ensures the production of drugs that meet the predetermined clinical efficacy, safety, controllability, and stability.
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Our company has a professional quality audit and verification team, with American returnees as the core of drug administration review experts and quality analysis research experts. They have rich management and review experience in domestic and foreign drug production, quality assurance, quality analysis, and formulation research and development systems. They can undertake quality management system inspection work at drug production and research and development sites, confirm the compliance of inspection sites, and provide scientific and compliant guidance to clients and inspection parties based on inspection results.
The inspection covers the qualification management of production material suppliers, the management of supporting public facilities systems for formulations, the compliance management of formulation research and development and production sites, the management of production and testing equipment, the quality assurance system, the management of quality testing and analysis methods, computerized systems and electronic data management, and the ability to control quality risks.
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Customer centered project management
Each project initiation/signing will establish a dedicated project team, which includes personnel in charge of formulation, analysis, registration, quality, and project management. The project team establishes a project communication group to discuss project progress and related issues at any time. The project manager regularly organizes project team meetings to discuss project phase plans, project progress, research results, etc., and promptly discusses and solves problems encountered during the project process. At the same time, the project manager will also communicate fully with the client team through various methods and channels, such as email, telephone/online meetings, face-to-face on-site discussions, etc., and report the project progress and problems encountered during the research process and their solutions to the client every two weeks to ensure that the project is carried out on time, compliantly, and efficiently.
