Business & Decision Life Sciences ensure a high level of quality in our clients’ products following the product specification and countries regulations where the products will be release.
- Broad knowledge of regulations, relative to product specifications:
=> QA model adaptation to pharma products, bio products, food products, medical devices and healthcare products
=> Deep understanding of market specific regulatory requirements
- Large expertise in the whole manufacturing process, giving us the ability to identify the critical manufacturing steps in order to focus the QA strategy on criticalities
- QMS implementation and adaptation supported by our broad overview on the QA strategy
- Great understanding of the different areas in which QA is applicable, such as R&D, QC, validation (CSV, CQV) and manufacturing
- Knowledge of specific QA-related tasks such as SOP writing, Deviation management, CAPA implementation, Batch release with a lean management perspective
- Lean expertise in addition to providing QA solutions (from green belt to black belt)
- Thanks to our Data expertise, we can bring you new solutions to handle and optimize your quality processes. We can develop software using data visualization, artificial intelligence and data governance. Through our data knowledge, we can bring tailored solutions for operational needs
Why choose us?
Business & Decision Life Sciences has been the trusted partner of major pharmaceutical companies these past years, supporting their Quality Assurance management.
We provide strong end-to-end support tailored to your needs thanks to our team of experts with strong knowledge in GMP and the current EU and FDA standards.