Supplier Management Services
The FDA’s Expectation Extends Beyond Supplier Qualifications, It Calls for Supplier Management Throughout the Product Lifecycle
Increased cost control pressures for manufacturers of FDA-regulated products have magnified expectations to control activities and materials provided by suppliers. After all, it is the responsibility of each organization to ensure that their suppliers provide services and materials that are fit for purpose throughout the product lifecycle, from product development through commercial distribution.
With this kind of increased scrutiny, a good supplier qualification process is simply no longer enough. ProPharma Group has extensive experience supporting pharmaceutical, biotechnology, and medical device companies through the entire supplier management lifecycle. Utilizing a supplier quality management lifecycle model, risk is managed through ongoing monitoring and trending of provided material and quality metrics. The result? Clear oversight from selection to qualification and management of your suppliers to ensure the safety, quality, and efficacy of the materials you need.
- Developing user requirements
- Supplier selection and due diligence
- Quality assessments
- Quality agreements
- Ongoing monitoring and control