Services

The KLS team understands that today’s medical/scientific affairs department plays a critical role in a company’s success and is an integral part of a meaningful compliance program. The KLS team is well versed in developing and implementing medical/scientific affairs strategies for all sizes of life sciences companies.

The life sciences industry constantly strives to deliver higher quality products in the face of stringent deadlines, regulatory hurdles and compliance requirements. To become and remain successful, you not only need the right facilities, processes and procedures, you need the right people.

To ensure that the true risks of clinical research and development are appreciated and managed, life sciences companies must protect themselves in an increasingly complex research environment. Most importantly, by effectively managing, risk life sciences companies can increase the chances that the goal of such research – bringing new and improved therapies to patients with unmet medical needs – is achieved.

The path to FDA approval of a drug or device is a long and winding process with differing nuances and complexities in each of the various approval systems. There are several avenues for FDA approval depending on whether the product is a drug or device. Additionally, there are different application processes for new drugs and generics of a branded drug.

Our team helps organizations transform risk and compliance efforts into competitive advantage by applying a risk lens to corporate strategy to improve risk intelligence and decision making, protect financial and reputational assets, and enhance business value.

KLS combines strategic thinking and emerging technologies to provide innovative solutions that align with industry regulations, guidelines and best practices for clients that seek to develop, redesign or modify corporate and/or product-related websites.