The research and improvement of drug quality have been highly valued by well-known pharmaceutical companies in various countries. The same medication may have variable impurity contents, bioavailability, and side effects depending on the drug's brand, generic, domestic origin, or importation. Its clinical safety and effectiveness are naturally different.
With rich experience in generic drug development, Our company provides professional consistency evaluation services to conduct drug consistency studies to improve and ensure the safety and efficacy of drugs. We have successfully completed a number of quality consistency evaluation cases and generic medication studies in the field of generic medicine quality consistency evaluation.
Service Overview
Quality conformance and efficiency conformance are included in the evaluation of generic drug conformity. In accordance with the specifications of national conformity assessment technical guidelines, Our company can offer generic solid dosage forms or slow-release formulation conformance evaluation research services.
Our services, which are supported by cutting-edge technology and a top-notch staff, include but are not limited to prescription evaluation/optimization, the similarity of dissolution of reference formulations in different media, types of impurities/attachments, stability studies, and work guidance for process validation. Finally, a comprehensive report of generic drug conformance evaluation will be provided for supplemental applications.
Our evaluation of the drug's quality focuses primarily on whether key quality indicators, such as solubility and associated constituents, are consistent with the reference formulation. The medicine maker must rework the product formulation procedure if quality is inconsistent. Bioequivalence assays are used to assess the consistency of effectiveness.
Research Capabilities
Our company will comprehensively compare the quality of reference formulations and generics.
- Discover the conditions for the determination of four dissolution curves of reference formulations and generic drugs and compare these dissolution curves.
- Determine the methods for the determination of relevant substances and isomers, and the determination of relevant substances, contents as well as isomers in reference preparations and generic drugs.
- Study of the crystalline form of APIs used in reference formulations and generic drugs.
- Stability studies (including influencing factors, accelerating influencing factors, long-term influencing factors, etc.)
Our redevelopment of the formulation process.
- Further studies on the quality of the original formulation.
- Full study of API properties.
- Optimization of the formulation process to ensure the durability of the above process through progressive pilot scale testing.
We have animal laboratories and testing centers that meet international accreditation. We are able to perform bioequivalence (BE) testing with animal subjects such as hunting dogs or crab-eating macaques, providing data to support formulation optimization and clinical BE risk reduction.
We complete analyses according to cusotmers' requirements and provide complete reports and accurate and compliant documentation containing high-quality raw data with traceability and high integrity.
Our Advantages
- Professional operation and team and complete quality assurance system to ensure the accuracy, authenticity, traceability and integrity of data.
- Efficient workflow, standardized operations, complete protocols, and report templates.
- Advanced instrumentation thus ensuring the efficiency and completion of projects.
- Good clinical research partners.
If you want to know more about service details, please feel free to contact us.
Related Services
It should be noted that our service is only used for research, not for clinical use.
