cGMPnow

cGMPnow is a US-based services firm founded in 2015 that addresses critical bottlenecks in building and qualifying GMP manufacturing facilities for advanced therapies. The company's core offering is an integrated, project-dedicated approach to delivering GxP systems—encompassing equipment, computerized systems, and compliance documentation—which are often siloed and delayed in traditional project models. By acting as a single point of accountability from design through qualification, cGMPnow aims to reduce timelines and risks for biotech and pharma companies, accelerating the path from facility concept to production. Its expertise spans autologous/allogeneic cell therapies, viral vectors, mRNA/LNP, and traditional biologics.

Integrated project delivery methodology for GxP system specification, procurement, and qualification. Expertise in Part 11 compliant computerized systems and strategic partnerships for end-to-end GMP facility solutions.

cGMPnow competes in a fragmented market that includes large engineering and construction firms (e.g., CRB, Jacobs), specialized validation and compliance consultancies, and in-house teams at biopharma companies. Its differentiation lies in its focused integration of equipment, systems, and CQV under a single, dedicated project team, specifically tailored for advanced therapy modalities.