Pharmaceuticals

Pharmaceuticals

Pharmaceuticals

Compliant & Cost Efficient –
Some questions we help our clients solve:

  • Am I keeping the balance between boosting efficiency and keeping up quality?
  • How can I effectively set up a truly operational Quality Risk Management process?
  • How can I transform my Quality Management system and approach?
  • We got a Warning Letter, what do we do now?
  • How can I tackle the increasingly complex requirements for registrations and change control procedures as well as regulatory filings of my products?

How we help to uQualize+ your business

We support you in transforming your business end to end, from supplier to customer, from quality to operations, from people to processes and practice. In case of an emergency, we offer fast and full remediation support. Some areas in which we help our clients are:

  • Design and execution of end to end business transformations of a single production line or an entire site
  • Set-up, monitoring and coordination of multi-workstream remediation programs to avoid future or remediate existing regulatory deficiencies
  • Design and implementation of Management System Owner networks to ensure state-of-the-art continuous improvement processes of Systems Quality
  • Optimization of QC processes and organizational structure including compliant lab-efficiency design
  • Introduction of Quality Risk Management processes and structures and design and execution of FMEAs

What’s up in the pharmaceuticals market…

Pharmaceutical producers find themselves in a double challenge on the global market. First, regulatory authorities become increasingly meticulous about quality standards and auditing compliance. Increased market transparency and consumer sensitivity regarding product quality and reliability, side effects of products, and investigative journalism on pharmaceutical corporations have incentivized authorities to become increasingly strict. Second, keen competition within the industry from producers in emerging economies force the established producers to work zealously on their cost structure, sometimes leaning out to an extent that product quality operations face resource challenges.