Case Studies

In addition to the specific deliverables of the project at hand, for every engagement we strive to deliver two overriding benefits to our clients:

Meet Regulatory Directives

  • Encourage early adoption of technical advances by the pharmaceutical industry
  • Implementation of risk based approaches that focus on industry and agency attention to critical areas
  • Ensure that regulatory review, compliance and inspection policies are based on state-of-the-art pharmaceutical science

Meet Business Needs

  • Maintain profitability by facilitating the efficient and effective introduction and operation of facilities, processes and equipment

Here are a few examples of our work.

Commissioning & Qualification
Consent Decree Remediation
New Process Train
Facility Expansion
Biologics Facility Start-Up