Bioequivalence evaluation of generic drugs is a long and complex process that covers preparation of the trial, trial conduct, sample collection, sample analysis, data processing, statistics of results, interpretation of results, document finalization and review.
Data is the cornerstone of any bioequivalence trial, and data management is an important part of pharmaceutical quality management systems. Bioequivalence evaluation data should follow the basic requirements of attribution, clear traceability, synchronous recording, original consistency, accuracy and authenticity. Complete, accurate, and thoroughly reviewed data will make generic drug applications smoother.
Our Services
As a high-tech company focusing on one-stop service for generic drugs, Alfa Chemistry provides robust and flexible solutions to generic drug manufacturers during this critical period of bioequivalence evaluation. Our company assists generic drug manufacturers in the design of bioequivalence trial protocols and is committed to providing an integrated compliance service from feasibility assessment to summary report submission. We always follow regulatory compliance guides and maintain effective communication with customers throughout the process to manage the implementation of bioequivalence trials.
Alfa Chemistry provides a full range of bioequivalence evaluation data processing and management services to generic drug manufacturers. Our business covers software and hardware services, which fully comply with the regulatory requirements of regulatory agencies in various countries to ensure the reliability, safety and traceability of trial data.
Our company has a laboratory information management system (LIMS) focused on bioequivalence evaluation, which is significantly different from the general LIMS. Our LIMS facilitates efficient bioequivalence study design and data transfer to help generic drug manufacturers easily achieve testing, validation, bioanalysis, instrumentation, sample tracking, result reporting, and regulatory compliance.
Our range of services
Our systems for sample analysis, data transfer, and statistical analysis related to bioequivalence evaluation have been validated and remain validated at all times. We ensure data integrity and processing integrity, ultimately helping our clients achieve full compliance.
- Assessment of trial feasibility
- Project planning and management
- Data processing for detection of biological and dissolved samples
- Experimental data management
- Comparison of generic and RLD trial results
- Summary report writing
Industry leading advantage
- We adhere to the principles of rigorous audit trail, complete rights management and secure raw data protection
- Our LIMS is validated
- According to the protocol, our system enables efficient, streamlined data processing
- Our data processing procedures comply with regulations
- We manage our customers' data responsibly, protect trade secrets, and make your data more secure
- Our integrated data management, data analysis and data documentation system facilitates data classification, storage and access
- We comprehensively compared the bioequivalence evaluation data of generic drugs and RLD and can analyze and interpret the data
- Our team is familiar with the features and caveats of bioequivalence trials of pharmaceutical products in different formulations
- Our experts have extensive experience in bioequivalence research and have served many generic pharmaceutical companies around the world
Our company makes bioequivalence evaluation data processing faster, ensures data reliability, and effectively controls risks to meet the needs of pharmaceutical data management in many ways. Work with us and let us process your bioequivalence data and manage it efficiently. Streamline your workflow, increase productivity and maximize profits with our technology and systems.
