Case Study

The first project we supported was preparing the client for an FDA audit, as they aimed to enter the U.S. market with Reduced Risk Products.

The client’s goal was to qualify their clean steam installation and verify that it meets the requirements defined in the URS and risk analysis, ensuring it provides clean steam with the desired specifications.

The client’s objective was to qualify laboratory equipment (biochemical analyzers) used for testing intermediates and final products in accordance with applicable regulatory requirements.

Subject – Entering the pharmaceutical market Our client is a prominent vodka producer and a leader in this economical segment, headquartered in Poland. With over 30 years of experience, they specialize in producing ethanol and bioethanol for the chemical, food, and pharmaceutical markets. The client’s objective was to enter the pharmaceutical market, requiring the attainment …

How was method validation achieved for entering pharmaceutical markets? Read More »

The client sought to validate two modules within a new system, P4Labs, developed to meet specific company requirements (GAMP 5 category). The modules included:

The client’s objective was to re-validate their clinical testing management system, comprising multiple modules. Following an audit deviation and the outcome of the periodic review, the client aimed to attain a verified state of the system, aligning with legal requirements and best practices.

Our primary task was to assist the client in meeting deadlines for qualifying approximately 40 devices. The objective was SIP* Cycle Development (CD). The plan was to provide documented evidence that the SIP process could fulfill the defined acceptance criteria,

The client aimed to achieve the best GMP standard for spirits production in Europe. Their goal was to differentiate themselves from competitors based on quality assurance, ensuring that customers would choose their products even in the face of slight price differences.

Operating within the European market, our client must adhere to EU regulations while also preparing for inspections from international bodies such as the United States Food and Drug Administration (FDA). Their validation processes lacked comprehensive documentation.