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Consulting Services

Driving Excellence in Chemical manufacturing & operations
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Don’t Settle For Less

Your Partner in Quality and Operational Excellence

We are a multidisciplinary consulting company specializing in supporting chemical manufacturing and handling operations.  With decades of experience across regulated and industrial sectors, we bring tailored expertise to help clients improve quality systems, streamline operations, and enhance long-term performance.

From setting up robust SOPs to optimizing production lines using lean methodologies and Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) , we are committed to creating measurable value for your business.

Quality Systems & Compliance

We specialize in building robust quality management systems tailored for chemical, biotech, and industrial clients. Our services include:

  • Development & review of SOPs

  • Internal audits and pre-inspection readiness

  • GMP, ISO, and EH&S compliance alignment

  • Equipment setup and calibration

  • Staff training & continuous improvement program

Our approach ensures traceability, repeatability, and audit-readiness across your operations.

Operational & Process Optimization

We identify bottlenecks, remove inefficiencies, and unlock performance potential using Lean, Six Sigma, and other proven methodologies. Services include:

  • Process mapping and value stream analysis

  • Elimination of non-value-added steps

  • Six Sigma / Lean implementation

  • KPI tracking and OPEX reduction strategies

  • OPEX and energy usage reduction strategies

  • Throughput and yield enhancement

Whether you’re scaling production or stabilizing quality, we help you meet operational goals.

Strategic Projects & On-Site Support

For facilities needing deep-dive technical support, we offer:

 

  • On-site assessments

  • Root cause analysis and problem solving
  • KPI definition and dashboard setup

  • Technical writing and document control 

  • Temporary embedded consulting

  • Vendor and materials evaluations

We are there to support you through your custom project execution.

INDUSTRIES & PROCESSES WE SUPPORT

Chemical Manufacturing & Blending

  • SOP Standardization & Batch Record Control — ensuring consistent documentation and reproducibility across blend batches.
  • Regulatory Gap Assessments (GMP, ISO) — site readiness for audits and certification.
  • Process Hazard Analysis (PHA) & Engineering Reviews — improved safety and reliability of blending operations.
  • OOS Tracking and Waste Stream Reduction — identification of unproductive cycles, off-spec batches, or overfills.
  • Tank Farm Optimization & Raw Material Handling — streamlined feedstock flows, reduced contamination risk, and improved inventory management.

Energy & Biofuels

 

  • Process Performance Audits  — benchmark and optimize throughoput the ethanol production processutility.

  • Training for Operator Competency in Quality — educate staff on proper GLP and GMP methodologies, laboratory techniques and processes.

  • Six Sigma Root Cause Investigations — identifying chronic process or control system issues to minimize downtime and maximize yield. 

  • Corn Oil Recovery or Heat Integration Optimization — increasing co-product quality and yield while decreasing energy spend.

  • Internal & Mock Regulatory Audits — preparation for FDA, Health Canada, and ISO audits.

Food & Beverage Processing

 

  • HACCP & FSMA – Based Quality Systems Support — design and implement traceability, lot control, allergen management.
  • Third-Party Audit Readiness (SQF, BRC, GFSI) — mock audits and corrective action roadmaps.
  • Line Efficiency Optimization  — reducing changeover times, bottlenecks, and mechanical delays.
  • Sanitation Program Effectiveness Reviews — CIP validation, swab testing routines, downtime analysis.
  • GMP-Compliant Documentation Systems — full lifecycle SOPs, validation protocols, and deviation tracking.

Specialty & Performance Chemicals

  • Lot Traceability and Quality Release Process Setup — customer-specific release criteria and documentation workflows.

  • Audit Support for ISO 9001 and Customer Audits — process walkthroughs, documentation review, interview coaching.

  • Customized Blending & Dosing Control Engineering — tuning of batch control systems or recipe optimization.

  • MSDS / SDS System Validation and Training — improving hazard communication and WHMIS compliance.

  • Yield Loss and Scrap Material Analysis — material balance studies and defect classification.

Pharmaceutical & Nutraceutical Production

 

  • Data Integrity Compliance and Documentation Remediation — digital and paper record review.

  • Validation Master Plan Development — including IQ/OQ/PQ templates and execution guidance.

  • Batch Size Optimization & Process Characterization — for scale-up or tech transfer support.

 

  • Engineering Review of Throughput and Downtime Issues — identifying automation or redesign opportunities.

     

  • Facility Workflow & Layout Redesigns — for safer, more efficient material flow and less handling duplication.

We Support Your Operations

Our consulting services are built for flexibility — adaptable to both regulated and industrial environments.

We understand the nuances of production, scale-up, and compliance across diverse sectors — and we speak your language.

Let us help you.

Get In Touch with us.

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Get In Touch

(519) 437-1540
hubert@p2i2.ca