cGMPnow


cGMPnow is dedicated to accelerating next-generation therapies to patients by providing comprehensive GxP system integration, real estate, and compliance services. Their mission is to bring new products to market faster through innovative project delivery and owner-focused involvement, emphasizing quality, regulatory compliance, and industry expertise.

Industries

biotechnology
manufacturing
pharmaceutical

Nr. of Employees

small (1-50)

cGMPnow

Boulder, Colorado, United States, North America


Services

End-to-end delivery of GMP systems including specification, equipment procurement, computerized system implementation, and CQV to enable facility GxP readiness.

Site selection, due diligence, design/build and leaseback advisory and make-vs-buy assessments for GMP manufacturing projects.

Quality systems support, compliance audits (including Annex 1), contamination control strategy development, and commercialization readiness support.

Execution of commissioning, equipment/facility/system qualification and validation activities to support GMP turnover.

Management of procurement and installation of manufacturing and laboratory equipment, including supplier selection and purchase coordination.

Advisory and management services to select contract development and manufacturing partners and to manage outsourced manufacturing projects.

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Expertise Areas

  • GxP systems integration
  • GMP facility design and engineering
  • ATMP and cell & gene therapy manufacturing support
  • Viral vector and nucleic‑acid therapeutic platforms
  • Show More (4)

Key Technologies

  • Aseptic processing and cleanroom systems
  • Part 11‑compliant computerized systems
  • Environmental monitoring and airflow visualization
  • mRNA and LNP production
  • Show More (4)

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