We provide efficient and quality-oriented pharmaceutical engineering consulting services.
We have a team of expert testers from various engineering fields capable of testing from physical conditions and mechanical equipment or installations to electrical devices and software. Our mindset is to critically look at testing subjects and try to detect and note down all anomalies so further improvements can be made to optimise equipment or systems. If you need independent and competent testing services with a precise and consistent approach, we can be your solution.
We execute standardized validation procedures according to GAMP guidelines and in alignment with customers’ internal company SOPs. Based on what is required we can provide full or only partial validation activities. In many situations we can also only guide the execution of validation activities aligning vendor and customer deliverables in a harmonised approach ensuring validation is done correctly.
In modern project management in most cases leading people without formal authority is required. To efficiently do this you must know the tools and leverages to use. It is very important how a project is organized and how communication, motivation and reporting are established. With extensive experience in project management, we know how to lead people with our social skills, assuring projects entrusted to our management always come to a successful end with praiseworthy results.
When the customer has its own internal team for the execution of validation activities but lacks the knowledge and experience or when it is established existing validation processes are not good enough or even when new validation concepts and processes need to be introduced into company’s regular business, we can provide our services to help achieve this in an efficient way. Our coaching approach will ensure processes are defined efficiently and people understand their purpose and learn skills to execute required validation activities.
A highly competent team was assembled to provide expertise from different fields of engineering required on projects in the pharmaceutical industry. Collaboration of youth and experience gives us additional advantages we use to be most efficient at everything we do. To better understand what we are capable of, team members’ presentations are available for our review.