GxP consultants fulfill an essential role in helping organizations maintain compliance, quality, and operational efficiency for market access to the regulated industries (pharmaceuticals, biotechnology, and medical devices). As global regulatory standards increase in complexity and stringency, companies are continuously turning to specialized consulting to help support safely navigating their compliance challenges while requesting speed, compliance, and innovation in their operating model. They provide strategic consulting support across a broad range of areas of need, such as quality management systems, data integrity, validation services, audit readiness, and GxP-focused aspects of digital transformation.

The GxP consultants' value addition enables companies with the needed change in order for organizations to align their internal processes with new guidelines, expectations, and industry best practices. GxP consultants leverage existing knowledge and awareness of existing systems to bring industry processing, eliminating wasted effort, inefficiencies, and redundancies, while persisting in getting through regulatory pragmatism, regardless of the GxP environment. They provide knowledge of the regulatory expectations, with risk-based thinking, and proprietary evidence-based decision making in renewing operating flexibility with operational change. While regulatory alignment may be the primary activity for these consultants,...