Our quality system supports compliance with Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), FDA and other relevant industry-specific guidelines.
View our EU certifications:
EU GMP Certificate – Human Medicinal Products (PDF)
EU MIA – Veterinary Medicinal Products (PDF)
We maintain comprehensive and accurate documentation including protocols, standard operating procedures (SOPs), batch records, test reports, among others. We employ a robust document control system to ensure integrity, accessibility and traceability.
Our team consists of highly trained and qualified professionals who possess the necessary expertise and experience to perform our services. We invest in continuous training and development programs to keep our personnel updated with the latest industry practices.
Our equipment undergoes regular calibration, maintenance, and qualification procedures to ensure accuracy, reliability, and traceability of results. Our testing facilities adhere to appropriate safety and security measures.
We have implemented a robust quality control program throughout the testing process. This includes the use of appropriate reference standards, internal quality control samples as well as conducting internal audits.
We continuously monitor and evaluate our processes to identify opportunities for enhancement. Feedback from clients, regulatory authorities, and internal assessments are key inputs for implementing improvements to our quality system.
Contact us to learn more about our assay development and testing services and how we can help you bring safe and effective drug products and biologics to market.
