Why must Quality Systems be there at the beginning?
Inglasia Pharma Solutions has supported various Pharma/Biotech startups with implementing their Quality Management Systems (QMS). At development and in early stage clinical trials, the QMS have been very much focused on ensuring compliance with documenting practices, training of personnel, management of vendors and ensuring the documentation around the development product is adhering to data integrity principles.
As these startups take their product through to late stage and even into commercial launch, we have further enhanced the QMS to accommodate the regulatory expectations of a licensed clinical trial /commercial product which can be medicinal product or a product used in the advancement of patient health management, such as artificial intelligence.
Starting with a QMS at the beginning, helps these startups with giving structure and direction for future expectations as the business starts to engage with the medicines regulatory agency. Setting a clear path for growth and cost effectiveness with a QMS that brings in efficiencies and more compliance as the business grows.
For a free 60 minute consultation on how we can support with the implementation and management of your QMS, please email us at firstname.lastname@example.org
Inglasia Pharma Solutions