How we work.

Clear phases, defined deliverables, and one accountable engineer at each gate. Engagements are sized to the work — a scoped deliverable, milestone oversight, a full program, or staff embedded in your team.

Delivery

Six phases, in order.

Each phase ends with defined deliverables and a go/no-go decision, so leadership sees a decision at every transition rather than a surprise at the end. Project engineering and management carries the thread across all six.

  1. PHASE 01

    Concept

    Turn a business need into a defensible project: capacity basis, options, order-of-magnitude cost, and the risks that decide whether it's worth pursuing.

  2. PHASE 02

    Design

    Lock intent before it's expensive to change: user requirements, basis of design, and owner-side review at each design milestone.

  3. PHASE 03

    Procurement

    Buy the right equipment from the right vendors, with FAT and delivery sequenced against the schedule.

  4. PHASE 04

    Construction

    Verify that what's built matches what was designed — while protecting the operations next door.

  5. PHASE 05

    CQV

    Bring systems to a documented, GMP-ready state with protocols that trace back to requirements.

  6. PHASE 06

    Handover

    Turn a construction project into a production asset: turnover packages, training, punch closure, and lessons learned.

Engagement

Shaped to the project

  • Defined scope

    A specific deliverable — a design package, a CQV package, a fit-gap assessment, a design review — with a clear start and finish.

  • Milestone oversight

    Part-time involvement concentrated at design reviews, gate decisions, FATs, and startup.

  • Full program

    Continuous, often on-site engineering and project management through the life of a project.

  • Embedded engineer or team

    Engineers, project managers, or CQV leads placed in your organization for the life of a program.

Standards

Codes and guidance we design and qualify against

Regulatory & Quality

  • 21 CFR Parts 210 & 211Current GMP for finished pharmaceuticals
  • 21 CFR Part 11Electronic records & signatures
  • EU GMP Annex 1 & Annex 15Sterile manufacture · Qualification & validation
  • ICH Q7 / Q8 / Q9 / Q10API GMP · Development · Risk · Quality systems

Commissioning & Qualification

  • ISPE Baseline Guide Vol. 5Commissioning & qualification
  • ASTM E2500Specification, design & verification of systems
  • ISPE GAMP 5Computerized system validation
  • ISPE Baseline Guides Vol. 3 & 4Sterile facilities · Water & steam systems

Mechanical & Process Design

  • ASME BPEBioprocessing equipment
  • ASME B31.3Process piping
  • ASME BPVC Section VIIIPressure vessels
  • API 520 / 521Pressure-relief sizing & selection

Facilities, Safety & Automation

  • ISO 14644Cleanrooms & controlled environments
  • NFPA 30 / 70 / 497Flammable liquids · NEC · Classified areas
  • ASHRAEHVAC design for controlled environments
  • ISA-5.1 / ISA-88 / ISA-95P&ID symbology · Batch · Enterprise integration

Let's talk about your project.

Tell us where it stands — concept, design, construction, or startup — and we'll come back within one business day.

Start a conversation (704) 500‑3033