One-stop integrated package service for consistency evaluation
Service 1: pharmaceutical research（CMC） Service 2: bioequivalence (BE) Service 3: generic drug consistency evaluation research service (pharmacological equivalence, bioequivalence, clinical effectiveness, etc.) Service 4: large clinical trial CRO service
Species that CFDA recommends exempting or simplifying bioequivalence testing (BE)
Oral solid preparation out of the 289 base catalog
Advantage 1 : Strong R&D team
Our R&D team has both solid theoretical knowledge and rich practical experience. They are proficient in drug R&D policies and regulations and they master the R&D process, methodology development, preparation technology development, and document preparation. All the project leaders have been engaged in the development of new drugs in large pharmaceutical companies for more than ten years. There are nearly 20 doctors and postdocs in our team, and the number of project teams is expected to reach 20.
Advantage 2 : State-of-the-art facilities and equipment We have 3 R&D bases in Beijing with a total area of nearly 10,000 square meters. There are more than 100 sets of HPLC, GC desk, atomic absorption desk, dissolution apparatus, infrared spectrometer station, etc. In addition, R&D bases also installed several sets of rotary tablet press, efficient coating machine, dry granulator, multifunctional fluidized bed and other well-known brand equipment.
Advantage 3: Perfect quality control system The company has established a management system cover R&D management regulations, instruments and equipment operation guidelines, SOP, validation guidelines and other quality control documents. All data is recorded and monitored, and we ensure all tests and inspections are standardized operated and real-time recorded.
Advantage 4：effective and strict confidential registry services Our registration team has close communication with the CFDA evaluation department, such as CDE and National Institutes for Food and Drug Control. We help design and conduct research in compliance with relevant regulations and guidelines of CFDA and its subordinate departments, and ensure that your dossiers are prepared correctly. It is necessary and important in the Chinese ever-changing regulatory environment.
Advantage 5：Scientific management system
（equipment and facilities）
Mainly undertake the product direction of consistency evaluationInjection
Consistency evaluation of pharmaceutical services
Determination of the source of reference preparation and raw materials
Pre-prescription studies to determine the key properties of API
Evaluation methods for determination of key indicators ( including the evaluation methods for dissolution)The comprehensive comparison of the quality between reference preparations and generic drugs
A comparative study on the overall quality of the report batch
Preparation formulation and technology optimization development research Stability analysis and validation
Preparation of application documentsThe establishment of generic drug quality standards