Pharmaceutical

Pharmaceutical companies are facing great changes— emerging science, shifting demographics, evolving regulations, evolving business models and increased stakeholder expectations. Developing a new drug within these confines is a race against time. Delays in bringing a drug to the market can cost millions of dollars each day. More importantly, delays prevent potentially life-saving treatments from being made available to patients.

At the same time, US regulatory enforcement action has increased dramatically in recent years. The FDA lists software validation among the top issues hindering the approval of these new therapies.

Many pharmaceutical companies struggle with the time, complexity and expense of recruiting qualified professionals for temporary or project-based compliance and validation work. These firms are choosing to outsource components of this work in an effort to keep in-house staff focused on development efforts while ensuring system quality and compliance issues are handled.

EngiSystems compliments your in-house expertise to help overcome staffing shortages and control costs. Partnering with us helps you concentrate on core business objectives, providing a cost-effective alternative for managing and maintaining systems quality, software validation and regulatory compliance efforts.