Services

COMMISSIONING & QUALIFICATION

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

VALIDATION

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

 


QUALITY SYSTEMS

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

REGULATORY AFFAIRS

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.


ENGINEERING

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

DATA INTEGRITY

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

TRAINING

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.