Project
EXCELLENCE
We have extensive experience with project management of pharma and biotech projects. High success rate of completion on time within the budget securing the right quality. User representatives in preparation of investment projects using the stage-gate model.
GMP & Engineering
PROFESSIONALS
Our trained GMP validation specialists are highly educated engineers with substantial knowledge of pharma and biotech production equipment, utilities, automation and processes and the required documentation.
Validation
DQ | IQ | OQ | PQ | PPQ | EMPQ
We have hands on experience with preparation of all validation documents from the design phase to completion of the project, test and qualification of pharma and biotech production equipment, classified facilities and utility systems and validation of processes.
Documentation
VPL | VMP | URS | SOP | FMECA | NC
We have solid experience and are highly competent in preparation of all kind of GMP documents within, nonconformity handling, risk assessments, validation and maintaining the validated state. FDA and EMEA inspection support.
GA2 are specialized in project management and validation for biotechnology and pharmaceutical clients. We can manage and execute the whole project, part of it or provide validation specialist assistance.
We have extensive experience executing both small and large projects within rebuilding, changes and GMP qualification of pharma and biotech equipment, utility and classified facilities.
GA2 consultants are engineers with long experience and in-depth validation knowledge of production equipment, utilities, and facilities.
We work as user representatives in projects as project managers, package owners, and specialists or assist a project team with specialist knowledge where parts of the project are carried out by us.
We have a high success rate in the completion of projects on time, within budget, and qua our specialist knowledge and hands-on experience with pharma and biotech, we can provide clients the right solution at the right quality level. We have a large network and experience in collaboration with other specialists and other contractors as we know from other projects.
For GA2 success of the client is paramount. We are well aware that time and money are essential in a competitive market.
We do our utmost to provide the service the clients request and need – no more no less – and to deliver in close collaboration with management, employees and other external service providers.
For us, it is crucial to secure the right GMP level and successful execution of your project right first time on time.
