Medicilon has successfully completed a number of quality consistency evaluation cases in the quality consistency evaluation of generic drugs. It has rich experience in the development of generic drugs and can provide you with more professional consistency evaluation services.
The “Conformity Evaluation of Generic Drugs” is mainly for the re-evaluation of the quality of the oral solid preparations of chemical generic drugs approved before the promulgation and implementation of the new version of the “Administrative Measures for Drug Registration” in 2007, mainly including tablets, capsules and granules. Investigate the consistency of pharmaceutical quality and efficacy. The pharmaceutical quality evaluation mainly investigates whether the dissolution rate and related substances and other key quality indicators of domestic generic and reference preparations are consistent. If the quality is inconsistent, the enterprise needs to carry out secondary development of the product prescription process.
Medicilon provides a consistent workflow for generic drug quality.
The integrated service platform for the quality consistency assessment of generic drugs in Medicilon can provide the following integrated services:
- Comprehensive comparison of the quality of reference preparations and generic drugs: Determine the measurement conditions of the four dissolution curves, determine the dissolution curves of the reference preparation and the imitation preparation, and compare the dissolution curves;
Determine related substances, isomers, etc., and determine related substances, contents, isomers, etc. of reference preparations and imitation preparations;
Study the crystal form of the API used in the reference preparation and the generic preparation;
Stability study (including influencing factors, acceleration and long-term);
- Secondary development service of prescription technology: Need to study the quality of the original research agent more deeply;
Fully study the nature of APIs;
Adjust and optimize the prescription and process, and ensure the durability of the prescription process through gradual enlargement;
Pilot scale-up/production technology transfer;
- Animal BE Service
The company has GLP-qualified animal laboratories and testing centers. Large animals such as beagle dogs or cynomolgus monkeys can be used for animal BE experiments to provide data support for formulation optimization and reduce clinical BE risk.
4. Report templates and SOPs Comply with customer requirements to complete the corresponding analysis terms;
Provide accurate and compliant documents;
Provide high-quality original data such as traceability and integrity, in line with CFDA requirements.
Advantages of Medicilon’s Quality Consistency Evaluation Center
- Professional work background, has successfully declared multiple generic drug varieties to FDA and CFDA;
- A complete quality assurance system to ensure the accuracy, authenticity, traceability and integrity of the data;
- Efficient work flow, standardized operation standards, perfect plan and report template;
- Advanced instruments and equipment, including optical fiber online detection automatic dissolution apparatus and GMP-compliant solid preparation pilot plant, etc., to ensure the efficiency and time of project completion;
- Have a good clinical research partner;