Compliance and Quality Assurance
Quanta’s Compliance & QA expertise has seen us take on major projects all over the world, including exciting destinations such as India & South Korea. Thanks to our large pool of global talent, along with our reputation for providing exceptional international mobilisation support, we’re able to source the best talent from all over the world for our valued clients.
When companies encounter Compliance and QA projects; then Quanta have a wealth of experience partnering organisations in delivering solutions to a wide range of issues (not exhaustive list of expertise):
· Site wide QA remediation programmes
· Responses to 483 warnings
· FDA Pre-Approval Inspection (PAI) programmes
· Global harmonisation programmes
· Data Integrity
Our work within the QA remediation sector has also seen our clients overcome FDA warnings and resume manufacturing, which is always our ultimate goal.
Our consultants know where to source contractors with experience on an international scale, and we provide compliance solutions to help make the process easier for both candidates and clients. With extensive local knowledge, Quanta will organise transport, accommodation, visas and immunisations, giving both clients and candidates peace of mind and the ability to focus on the work at hand.
These resources cover a wide range of manufacturing areas, including (but not limited to):
- Primary biotechnology (upstream/downstream)
- Secondary (pharmaceutical and biotech)
- Formulation fill/finish
- Oral solid dosage
- Medical device
- Veterinary products
- Combination products
- Gene therapy