Our Services

Strategy and Execution


We can define and develop the strategy for our partners and also execute the strategy with confidence.

  • GMP Infrastructure Startup & Support
  • Manufacturing, Technical Operations Strategy
  • Make vs. Buy Business Case Analysis
  • Due Diligence
  • Program Management
  • Marketing
  • Finance & Project Controls
  • Talent Sourcing & Human Resources
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    Capital Projects, Tech Transfers and Facility Builds

    We provide the following support for capital projects, tech transfers and facility builds. We also backfill key project management, construction, technical and engineering roles.

  • Program & Project Management
  • Facility Design
  • CMO / CRO Selection & Management
  • Vendor Selection & Management
  • Equipment Selection & Procurement
  • Infrastructure Support: Finance, Legal, IT & Marketing
  • Scope, Schedule & Budget Management
  • Backfill Key Technical Roles
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    Capital Projects & Facility Builds


    We understand the different validation requirements for GMP, GLP, and GCP systems and various FDA, EMA, and other global regulations. We cover the gamut of validation services such as:

  • Traditional Commissioning & Qualification
  • Validation Program Development
  • Validation Maintenance
  • Process Validation
  • Computer Validation
  • Cleaning Validation
  • Steaming Validation
  • Laboratory Validation
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    Quality, Regulatory and Compliance

    Our experience includes QMS, policies and procedures for both ISO certification and global GMP compliance in addition to data integrity, audits, CMO management, regulatory, compliance remediation, QRAs and more.

  • Policies & Procedure Development
  • Quality Management Systems
  • Data Integrity (Part 11 compliance)
  • Auditing (CMOs, Vendors, Computer, IT)
  • CMO Management, Quality Agreements, PIP
  • NC & CAPA Program Development
  • Regulatory Submissions, Audits, Remediation
  • Quality Risk Assessments
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    Quality, Regulatory & Compliance

    Engineering, Automation and Serialization / Track & Trace

    We are a versatile system integrator providing turnkey engineering services. We have subject matter expertise in small and large molecule facilities (including biologics and advanced therapies) and their equipment and technology.

  • Preliminary, Conceptual & Detailed Facility Design
  • URS, FS, DS
  • Equipment Design, Selection & Procurement
  • Vendor & Asset Management
  • Change Control Ownership
  • Part-11 Compliance
  • Facility Utilities: Mechanical, Electrical & Plumbing
  • System Owner & Process Engineering
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    Engineering & Automation

    Reliability, Maintenance and Asset Management

    Our offering encompasses the complete asset management lifecycle starting with program and department creation. We can lead resource modeling and creation of policies and procedures, schedules, budgets, and operations to maximize production uptime.

  • Operations & Maintenance Staffing
  • Group Identification & Organizational Charts
  • Policies, Procedures & Training Materials
  • Asset Management Strategy
  • EAM & CMMS Selection
  • EAM & CMMS Optimization
  • Facility Gap Assessments & Optimization
  • Quality by Design Principals
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    Reliability & Maintenance

    Cell & Gene Expertise, Who is Project Farma? & Thought Leadership