Our vision

Be a transformational agent in the life sciences industry, bringing more innovative approaches to organizations and impacting their internal processes for medical device, pharmaceutical and life science firms.

Who We Are

EngiLifeSciences is a consulting firm and provides consultation services to the medical device, pharmaceutical, and biotechnology industry. The company’s consulting expertise encompasses software compliance, software technology, computer system validation, quality systems, and quality and business performance characteristics.

Services we offer

We offer an array of services that are targeted at increasing the bottom line of an organization. In the quality systems area, we help with process improvement including compliance. Addressing the regulatory concerns and issues, we assist our clients in transforming their processes to a compliant state and also help in remediation of various areas of the quality systems. When it comes to quality and business performance, EngiLifeSciences focuses on product development, manufacturing, information technology, quality systems, and how these processes can integrate to offer end-to-end visibility, helping organizations identify opportunities. This visibility enables organizations to pinpoint their internal challenges and confront them immediately instead of dealing with them later unprepared.

Our approach

We utilize our propriety solutions, the MEV Grid and 3PO Model. We begin with an assessment process, and a part of the process is helping clients understand their strategic objectives. Following that, we conduct tailored studies at different levels in an organization, all the way from management, performance management area, to the training of company personnel. We also assess the vitality of the organization’s structure and the supporting business requirements and analyze these studies to help CEOs identify opportunities that they are not aware of, which oftentimes act as an eye-opener to them. Today, CEOs in the diverse industries are challenged with the lack of end to-end visibility, and they often strive to enhance operational efficiency while increasing agility. These studies help discern the gaps that may lie within the organization and meet the objectives. We also aid organizations in determining if they are incognizant of any internal regulatory compliance risks.

Decades of proven results

EngiLifeSciences portfolio is extensive. It includes an optimization project for one of the largest medical device manufacturers, a global enterprise that was looking to reduce the overhead in their computerized system validation process. We collaborated with the organization, interviewed 27 teams across the organization and helped them streamline and standardize some of their processes. Within a small window of time, EngiLifeSciences was able to reduce the client’s overall operational cost by 20-30 percent, the identified saving being more than 25 percent. This is just one of the many examples of proven results.

A future of innovation

Moving ahead, EngiLifeSciences is focusing on the process areas of the quality systems to introduce automated solutions that are more integrated. We are also looking to accelerating and increasing visibility within organizations with the 3PO Model to help identify opportunities and positively impact the bottom line. We are aiming to implement technology to improve the visibility so that executives and CEOs have a clear understanding of their internal processes and help their organizations become more agile and adaptable to external changes that occur.

Synergistic Outcomes

Blended thought leadership with a dynamic execution team.

Checks and Balances

Accountable structure to manage the quality and productivity of the teams and compliance.

Strategic Team Development

Alignment of teams to meet business objectives.

Collaboration & Communication

Communication and integration of team members for optimized results.