Due to injection's unique use and mode of action, its quality, safety and efficacy are of paramount importance. Consistency evaluation of injectables requires a comprehensive assessment of product standards, production processes, stability, and bioequivalence. Quality control and the implementation of standard operating procedures are required during the evaluation process.
Different countries and regions have different regulatory requirements for generic injection consistency evaluations, so the sponsor needs to fully understand and follow the regulatory requirements when conducting a consistency evaluation. In addition, it is necessary to pay close attention to updates to relevant regulations and adjust the evaluation strategy in time to meet the latest regulatory requirements.
Our Services
Consistency evaluation for injectables is time-consuming and complex. Many pharmaceutical companies may encounter various challenges during the application process due to insufficient resources and experience.
Alfa Chemistry provides integrated generic development and registration services for global pharmaceutical companies. After years of deep cultivation in the field of generic drugs, we are familiar with the application process of consistency evaluation for injection, the regulatory requirements of FDA, EMA, NMPA and other regulatory agencies, and the matters that need attention when applying.
Our company provides professional regulatory consulting services to help pharmaceutical companies understand the regulatory requirements of their countries and regions.
Our company customizes targeted and effective service solutions according to the specific needs of pharmaceutical companies to ensure that the customer's consistency assessment declaration is successfully passed, and ultimately achieves the successful marketing of the product.
- Preparation of Application Information
We assist our clients in preparing detailed information, including quality standards, production processes, stability data, bioequivalence test results, etc.
We work with companies during the application process to ensure that the quality of each batch of injectables meets the standards of the originator drug, which includes reviewing test data for intermediate and final products, as well as assessing the accuracy and completeness of labeling and packaging information.
Stability testing is an essential part of the application process. We provide accelerated stability testing and long-term stability testing services to demonstrate the quality and stability of injectables before the expiration date.
Bioequivalence testing is a necessary segment to ensure that generic injectables have the same efficacy in vivo as the originator drug. Our injectable bioequivalence tests are conducted under GCP-compliant conditions to ensure the reliability and validity of the results.
Consistency evaluation of injectables is particularly important as they directly enter the human circulatory system, and drug regulatory agencies in various countries have put forward higher requirements for quality control and consistency evaluation of injectables. Pharmaceutical companies should understand the regulatory requirements, master the technical points, and pay attention to the application strategy during the application process.
We have set up an experienced team of professionals who are well versed in the regulations and application process in different countries, and are able to provide high-quality consulting and support services. We maintain long-term communication with regulatory agencies and provide one-stop services for global generic companies in the application process, from data preparation, trial implementation to application submission, to ensure an efficient and orderly process.
