Expertise

Cell and Gene Therapy Manufacturing Consulting

Expertise

Cell and Gene Therapy Manufacturing Consulting

Whether you’re building a new cell and gene therapy facility or repurposing an existing site, our industry professionals can help you plan for all direct and not direct impact systems needed, ensuring engineering designs are accurate and set to meet cGMP requirements.

A seasoned CQV project sponsor will ensure your facility gets the best care and clear communication throughout your project, giving your quality teams peace of mind that you will meet your launch dates. Lean on your continually updated, customized project dashboard for the latest financials, schedule adherence, and opportunities to mitigate risks or improve processes.

Define Best Practices, Don’t Chase Them

When people are awaiting your life-saving and life-altering treatments, who will you trust to get the job done right the first time?

Cell and Gene Therapy Manufacturing Consulting

Whether you’re building a new cell and gene therapy facility or repurposing an existing site, our industry professionals can help you plan for all direct and not direct impact systems needed, ensuring engineering designs are accurate and set to meet cGMP requirements.

A seasoned CQV project sponsor will ensure your facility gets the best care and clear communication throughout your project, giving your quality teams peace of mind that you will meet your launch dates. Lean on your continually updated, customized project dashboard for the latest financials, schedule adherence, and opportunities to mitigate risks or improve processes.

Define Best Practices, Don’t Chase Them

When people are awaiting your life-saving and life-altering treatments, who will you trust to get the job done right the first time?

ICQ in Action

Building success for contract manufacturing.

“I have never seen a firm as flexible, creative, or able to bring on additional staff as our needs evolve.”

Chris Holmes
VP Facilities & Engineering
Paragon (now Catalent)

Chris Holmes
VP Facilities & Engineering
Paragon (now Catalent)

Paragon (case study heading image)

Cell & Gene Therapy Expertise

  • Commissioning and qualification program development
  • Comprehensive validation planning and execution
  • Quality procedure audits
  • Quality management system alignment
  • Strategic gap assessments
  • Operational and inspection readiness
  • Project controls
  • Facility start-up
  • Change management processes
  • GMP facilities
  • Biomanufacturing facilities
  • Gene therapy manufacturing facilities
  • CDMO facilities
  • Single-use facilities
Contact Your Local Rep

Contact Your Local Rep