Navigating the Regulatory Landscape - EngiLifeSciences
Computer System ValidationRegulatory & Compliance

Navigating the Regulatory Landscape

By August 8, 2018 No Comments

The regulatory landscape is dynamic in nature, constantly evolving and changing at an accelerated pace. Keeping up with the changing regulations can be an uphill task for organizations in highly controlled industries. EngiLifeSciences is committed to unraveling the complexity of regulatory compliance in the life sciences industry.

Our mission is to help enterprises bring high-quality, compliant products to the market using their cutting-edge compliance and managed consulting solutions. We provide consultation services to the medical device, pharmaceutical, and biotechnology industry. EngiLifeScience’s consulting expertise encompasses software compliance, software technology, computer system validation, quality systems, and quality and business performance characteristics. 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, we focus on product development, manufacturing, information technology, quality systems, and how these processes can integrate together 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.

For compliance challenges and regulatory changes that occur in the life sciences industry, EngiLifeSciences has devised the MEV Grid™ which stands for maturity, efficiency, and visibility. The grid embeds end-to-end visibility, maturing processes, and efficiency within the processes and technologies in an organization. We have also developed a 3PO Model™ that can help our clients identify opportunities, which can impact the bottom line within the first year we do the assessment. EngiLifeSciences 3PO Model helps in driving operational efficiency so that when industry changes occur, there is a lower implementation cost and higher efficiency and execution.

One of our main objectives is to be a transformational agent in the life sciences industry, bringing more innovative approaches to organizations and impacting their internal processes so that they are more adaptable to the external changes occurring in the industry. We help organizations keep pace with the rapidly changing regulatory ecosystem and become more agile so that they can attune faster to the external conditions in the market.

To learn more about how EngiLifeSciences can help your company, contact us below!

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