There are many varieties and a huge number of generic drugs currently on the market, with varying quality and very different efficacy, and there is a certain gap between the quality of the reference listed drug (RLD). Therefore, generic drug consistency evaluation is imminent. Generic drug consistency evaluation is actually a re-evaluation process. Alfa Chemistry is committed to providing professional generic drug consistency evaluation services for global clients, aiming at eliminating varieties that fail to meet the quality and clinical efficacy requirements through re-evaluation of the quality and efficacy of generic drugs, improving the pharmaceutical standard, standardizing the pharmaceutical market, and guaranteeing the safety, efficacy, and economic convenience of people's use of medicines.
The connotation of generic drug consistency evaluation is drug therapeutic equivalence, including pharmaceutical equivalence and bioequivalence. Among them, pharmaceutical equivalence refers to the similarity of the pharmaceutical properties of generic drugs and reference preparations, including raw materials and excipients, dosage forms, prescriptions, processes, in vitro experiments, and other studies. Pharmaceutical equivalence evaluation is the basic requirement for generic drug consistency evaluation.
Alfa Chemistry's Services
Pre-prescription Research of Generic Drug
We offer reliable generic drugs pre-prescription studies, including studies on the physicochemical properties of active ingredients and excipients, reverse engineering of the reference listed drugs (RLDs), quality control methods, product life cycle management, etc.
Prescription Process Studies of Generic Drug
We provide comprehensive generic prescription process research services, and we perform the development, optimization and validation of prescription process after completing a thorough research and analysis of the prescription of the RLD. The optimal prescription process is provided when the scale-up research is finished.
Quality Consistency Evaluation(QCE) of Generic Drug
We provide reliable quality consistency evaluation (QCE) services for global customers, including the establishment and determination of quality standards, methodological verification of quality standards and comparative studies of impurities.
Stability Studies of Generic Drug
We provide professional generic drug stability evaluation services, including testing packaging compatibility, stress , accelerated stability, long-term stability, and expiration date, etc.
Safety Evaluation of Generic Drug
We provide reliable and high-quality generic drug safety evaluation services, mainly through toxicological, pharmacological, and histopathological verification.
Extractables and Leachables Testing
Our company provides affordable and efficient extractables and leachables testing services to generic drug manufacturers to ensure that substances that may be hazardous to human health are not generated during production, storage and use.
Pharmaceutical equivalence evaluation is a critical process to ensure the safety, efficacy and quality of generic drugs. Alfa Chemistry is a trusted partner for generic drug consistency evaluation. Through rigorous analytical methods, in vitro studies, stability assessments and regulatory support, we aim to help our clients bring high-quality generic drugs to market.
