Our PharmEng professionals have extensive experience in the development, implementation and execution of:

  • Enhanced Detail Design Reviews - Design Qualification (DQ)
  • Risk Management Tools
  • Commissioning / Qualification / Validation Master Plans
  • Project Management Tools (Budgeting, Scheduling, Tracking, Resource Planning)
  • Facility / Utility System Commissioning Test Procedures
  • Critical Utility System Qualification (IQ/OQ/PQ) Protocols
  • Process Equipment and Process System Qualification (IQ/OQ/PQ) Protocols
  • Controlled Temperature Units(IQ/OQ/PQ) Protocols
  • Process Control Systems(IQ/OQ/PQ) Protocols
  • Packaging Lines(IQ/OQ/PQ) Protocols
  • Laboratory Instrumentation (IQ/OQ/PQ) Protocols


PharmEng has an extensive background in completing Validation Projects; these include cleaning, facility and utility, equipment, process, and computer validations.



With years of experience serving renowned clients in biotechnology, pharmaceuticals, medical devices, and nutraceuticals industries, our specialists follow a systematic approach to identify, assess, and successfully resolve a wide range of quality system issues that can be seriously damaging to our clients’ business. We are proud to offer you our world-class quality system services in the following:

  • Quality management consultation and training
  • ISO and cGMP implementation
  • Gap and quality performance analysis
  • Quality system documentation
  • Audit and inspection management
  • Risk and crisis management
  • Comprehensive validation services


PharmEng supports Pharmaceuticals, Biologics, Over-The-Counter (OTC), Animal Health, Radiopharmaceuticals, Clinical Trial Products, Medical Devices, Combination Products, Natural Health Products, Personal Care, Disinfectants, and Active Pharmaceutical Ingredients (API) to achieve the most cost-effective way to undertake their regulatory activities worldwide. This includes regulatory intelligence and strategy, worldwide product registration, preparation of regulatory documents, in country representation, establishment registration, and post-approval submissions.


Our experts have successfully completed facility and process engineering projects including; vaccine manufacturing, sterile manufacturing, oral solid and liquid dosage manufacturing, API manufacturing, medical device manufacturing, and more.

We offer a full range of services including:

  • Facility and process planning and design
  • Automation and process controls
  • Pharmaceutical process engineering
  • Facility and process validation
  • Occupational health and safety management
  • Environmental impact management


Our experience has allowed us to develop the following tools for tracking all types of Data Integrity issues:

  • Draft protocols and reports
  • Prerequisite checklists
  • Outlines for testing procedures
  • Distinct and detailed frameworks
  • Remediation plans


PharmEng has been providing training programs to regulated industries for more than a decade. We customize our programs to fit client needs. Our course offerings include: cGMPs/ GLPs, Validation, Engineering, Regulatory Affiars, Quality Assurance, Manufacturing Processes, and more. 

Our instructors are experienced professionals with diverse backgrounds from industry, government and academia. Course materials are developed in-house and are constantly updated to keep current with industry practices and changing regulatory environments.

The courses we provide include real-life examples from industry, with case studies and hands-on exercises to illustrate concepts.