Mastering Regulatory Requirements –
Some questions we help our clients solve:
- How can I address increased regulatory pressure?
- How do I structure my Quality Management System efficiently?
- How do I set up an effective and efficient SOP Landscape for my processes?
- How do I effectively manage Regulatory Intelligence operations?
- We got a Warning Letter. How do we get this solved?
How we help to uQualize+ your business
We support you in the design and set up of your quality operations, and make you target optimal levels in the solutions to optimize your processes and facilitate good decision-making. Some areas in which we help our clients are:
- Design and implementation effective SOP documentation systems
- Introduction of Quality Risk Management processes and structures as well as design and execution of FMEAs
- Design and implementation of Quality Management organizations within the company
- Design and execution of end-to-end lean transformation of factories
- Optimization and streamlining of Quality Control processes
- Full scale wrap-around support for remediation programs in Warning Letter and regulatory emergency situations
What’s up in the cosmetics market…
Regulatory compliance has increased drastically over the past years. Departments of Regulatory Affairs are required to be fully familiar with respective legislation, which differs from country to country. Due to more intricate regulations and reporting requirements, costs are massively increasing as more time and staff is required. An intensified public interest on QA and regulatory compliance touches on aspects of workplace safety standards as well as product liability, which is further increasing regulatory attention and FDA warning letter listings.