GxP is a set of regulations and quality guidelines that aim to address the safety of the pharmaceutical product in a systematic and wholesome manner while maintaining the quality of processes throughout every stage of manufacturing, control, storage, and distribution. We can establish Quality Control systems with demand precision, accuracy, robustness, and reliability.

We develop, implement and maintain Quality Systems according to the needs of each company for enhanced resource management and results. We secure validation project success from URS to PQ. With Computer System Validation (CSV) we test, validate and document to ensure secure, reliable and traceable service.  We can optimise new or existing methods, documentation according to regulations, evaluate, develop and implement GxP quality system.   

With electronic data in highly regulated environments such as pharmaceutical and medical device industries we provide paperless record
- keeping systems (21 CFR Part 11 System). We ensure to produce data accurately and consistently, create an indelible electronic data trail that is transparent, traceable, and protected. Store those electronic data records in a way that is safe and secure.

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