Equipment & Utility Qualification
IQ/OQ/PQ tailored to the specific client needs based on a phase and risk-based approach utilizing PDA, TR, FMEA to ensure product quality and data integrity.
HomeServices
Our services
A full suite of GMP consulting solutions.
Three connected service groups spanning validation, engineering and facility start-up, and quality. Explore the capabilities and scope within each.
01 / 03
Validation Services
Full lifecycle validation support, from risk assessment and master planning through protocol execution, documentation, and regulatory approval. Our validation programs are built to FDA, EMA, and ICH standards and scaled to the complexity of your facility and process.
Cleaning & Analytical Method Validation
Cleaning validation strategies and analytical/microbiological method validation per ICH and USP guidelines.
Enterprise System Implementation
End-to-end deployment of ERP, MES, and LIMS platforms including site-wide qualification master plans and data integrity frameworks.
Validation Master Planning
Site-wide VMPs for greenfield and brownfield facilities. Periodic reviews and lifecycle management to maintain validated state.
Capabilities
& Scope
& Scope
Data Integrity & Audit Trails
ALCOA+ implementation, audit trail reviews, and SOPs compliant with 21 CFR Part 11 and FDA data integrity guidance.
Cross-Industry Applicability
Validation principles across pharma, biotech, cell & gene therapy, medical devices, and sterile/non-sterile environments.
CSV & 21 CFR Part 11 Compliance
GAMP 5-aligned validation of MES, LIMS, ERP and lab systems. Full audit trail controls and electronic records compliance.
02 / 03
Engineering and Facility Start-Up
Capital project engineering, powering both greenfield and brownfield facilities from concept through start-up and commissioning. We deliver inspection-ready facilities and systems on time, accelerating timelines while ensuring zero critical compliance gaps.
Continuous Improvement and Process Optimization
Utilizing performance data and digital tools to optimize maintenance, utilities, and workflows. By streamlining processes and adopting predictive strategies, teams reduce downtime, improve efficiency, and extend asset life. All improvements are implemented within a controlled, compliant framework to ensure systems remain validated and inspection-ready.
Capital Project Execution & Start-Up
Technical lead during facility construction and commissioning. Cross-functional team management from scale-up through inspection readiness.
Capabilities
& Scope
& Scope
Greenfield & Brownfield C&Q Strategy
Commissioning and qualification strategies standardized across new and existing facilities. Achieved on-time operational readiness with zero critical compliance gaps.
Vendor & Contractor Oversight
Management of specialist consultants and vendors across multi-discipline programs. Timeline tracking & milestone reporting throughout.
03 / 03
Quality (QS, QE and QO)
Embedding quality at every level of your operation, from strategic quality system design through shop-floor execution. We build systems that are audit-ready from day one and sustainable beyond any single inspection.
QMS & Document Control
SOP development, change control programs, training record systems, and quality documentation, built for regulatory scrutiny.
Quality Engineering & QbD
Design for quality, risk-based process evaluation, out-of-trend remediation, and statistical analysis across development and manufacturing.
Quality Operations Support
Batch record review, shop-floor GMP oversight, release readiness, and operational quality execution for clinical and commercial programs.
Capabilities
& Scope
& Scope
Deviation & CAPA Management
Root cause analysis (5M, Ishikawa), CAPA governance, deviation resolution, and corrective action tracking to verifiable closure.
Inspection Readiness & Regulatory Strategy
FDA/EMA inspection prep, mock audits, regulatory strategy development, and SME support during regulatory interactions.
GMP Culture & Training
GMP culture assessment, team training programs, and quality mindset development, making compliance sustainable across your organization.
Quality First
Let's build compliance with confidence.
Contact us today for a complimentary scope discussion and project assessment with one of our founding consultants.