Services

Project Controls

Services

Project Controls

ICQ provides project control services through all phases of greenfield and brownfield capital projects, including conceptual design, basis of design, detailed design, procurement, construction, mechanical and substantial completion, as well as CQV and other project deliverables.

Our dedicated Project Managers assigned to each quality team are your first step to quality. Your Project Manager is responsible for all schedules, budgets, and documentation for complex commissioning, qualification, and validation projects so your internal team can handle other mission-critical responsibilities.

Two Heavy Industry Engineers Stand in Steel Metal Manufacturing Factory, Use Digital Tablet Computer and Have a Discussion.

ICQ provides project control services through all phases of greenfield and brownfield capital projects, including conceptual design, basis of design, detailed design, procurement, construction, mechanical and substantial completion, as well as CQV and other project deliverables.

Our dedicated Project Managers assigned to each quality team are your first step to quality. Your Project Manager is responsible for all schedules, budgets, and documentation for complex commissioning, qualification, and validation projects so your internal team can handle other mission-critical responsibilities.

People with Passion

Guided by our principals’ 75+ years of combined experience in pharmaceutical manufacturing, our extensive network of pre-screened, skill-assessed CQV experts are at the ready to deploy to your facility as soon as you request them, significantly shortening onboarding timelines so you can reach your milestones.

Each of our 500+ qualified engineers, construction managers, project managers, and technical leads is well-versed in strategic biopharma CQV planning, management, and execution to ensure your engineering designs are accurate and set to meet cGMP compliance requirements. Contact us to get matched with the right CQV professionals to augment your staff or execute your capital project.

Client Support

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)

Project Controls Services

  • Dedicated Project Sponsor
  • Project Planning and Execution
  • Scheduling
  • Budget and Cash Flow Tracking
  • Procurement Planning
  • HSE Planning
  • Document Control Planning (Good Documentation Practice)
  • Quality Planning
  • Pre-commission and Qualification Alignment
  • Integration of Commissioning and Qualification
  • Assistance with Compliance Audits
  • Development and Management of Compliance Action Plans
  • Regulatory Readiness Inspections and Training
  • Response to Regulatory Citations and Warning Letters
  • Design of Quality Systems for New Facilities or New Process Lines
  • Ongoing QA/QC Support
  • Preparation of Regulatory Filing and Review Documents
  • Implementation of Quality by Design (QbD), ICH-Q8, ICH-Q9, ICH-Q10, ASTM E2476, and ASTM E2500 Principles and Approaches
  • Project Close-out Planning

Project Controls Services

  • Dedicated Project Sponsor
  • Project Planning and Execution
  • Scheduling
  • Budget and Cash Flow Tracking
  • Procurement Planning
  • HSE Planning
  • Document Control Planning (Good Documentation Practice)
  • Quality Planning
  • Pre-commission and Qualification Alignment
  • Integration of Commissioning and Qualification
  • Assistance with Compliance Audits
  • Development and Management of Compliance Action Plans
  • Regulatory Readiness Inspections and Training
  • Response to Regulatory Citations and Warning Letters
  • Design of Quality Systems for New Facilities or New Process Lines
  • Ongoing QA/QC Support
  • Preparation of Regulatory Filing and Review Documents
  • Implementation of Quality by Design (QbD), ICH-Q8, ICH-Q9, ICH-Q10, ASTM E2476, and ASTM E2500 Principles and Approaches
  • Project Close-out Planning

How Can We Help You Get It Done Right?