- Reduce the costs of non-quality !
- Understand manufacturing processes for better control !
- Attain consistent product quality !
- Ensure FDA and EMA compliance in process control !
In order to ensure that the above can be achieved :
We announce the creation of « PAT-EXPERTS », first innovative and operational Pole of expertise and skills, at the service of the bio-pharmaceutical, cosmetic & chemical industries to bring industrial projects in the fields of product & process development with integration of PAT to successful conclusions.
This pole brings together the skills of Inhalexpert with expertise in Quality by Design for product and process development, NIR-Industry with expertise in Process Analytical Technology (PAT) and Galenisys Pharmaceutical Consultants, leader in equipment qualification and process, and analytical method validation and transfer.
This synergy of service will bring together the pragmatic approach of “Quality by Design”, to define critical sources of process variability, with “Process Analytical Technology by NIR & Raman”, to monitor, manage and improve processes in order to ensure that final products are manufactured consistently with the desired quality.
Equally, analytical methods involved in Quality by Design and PAT will be validated and prepared for regulatory filings. This will take into account the specific requirements of the FDA and EMA for analytical method registration and for changes to analytical methods including the use of NIR technology.
Operational use of our services will ensure that manufacturing processes and finished products can be managed successfully with, an increased level of product and process knowledge, improved process control, consistent and appropriate final product quality and reduction in the cost of non-quality.