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IPS

Maximizing Value

Our technical consulting streamlined the engineering and validation process and implementation for our client. Our strategies were based upon the risk- and science-based approach applied to the F&E Lifecycle of Design, Specification, Construction and C&Q. 

Qualification / Validation

Our services are based on providing a strategic, value added approach to our clients. Our key differentiator is our alignment with our client’s compliance and business drivers to deliver best value while maintaining full compliance.

We have successfully executed a broad range of projects from one day technical consults up to the implementation of full-scale programs for $250MM facilities.

As a strategic partner, we had executed projects all over the world for small virtual companies to large multi-national branded, generic and contract manufacturers.  Our services cover facilities, facility and critical systems, process equipment and processes (including cleaning) for all drug substance and drug product forms as well as medical devices and combination products.   We are currently assisting several clients in the areas of Isolation/RABS technology, both sterile and potent, for large and small molecule formats and in Biomanufacturing, including bulk substance and purification.

With over 22+ years of hands-on experience, IPS offers a comprehensive approach to understanding the regulations and validating the process to ensure the consistency and quality of the manufactured product. Our team of experts offers practical understanding and scientifically-based methodologies for risk- and science-based investigations, audits, remediation and quality system development services to assist you with your organizational needs.  Our consultants are currently engaged on several projects assisting clients with implementing risk-based concepts at company/corporate level as well as project level. We recently executed the first E2500 implementation in India. 

 Our application of industry accepted project management approaches, lean concepts along with our collective experience allows for efficient projects as well providing a baseline for better Cost of Goods Sold related to the Life Cycle areas impacted by C&Q activities.  

 Comprehensive Services to Maximize Value

  • Rationale / Strategy Development
  • Validation Master Planning
  • Facility and Facility System Qualification
    • Test Plans
    • Factory Testing
    • Site Testing
    • Turnovers
    • Maintenance and Calibration Programs
    • Field Testing
    • Acceptance Reporting
    • Deviation Resolution
    • Quality System Implementation
  • Validation / cGMP Training
  • Validation .Life cycle Cost Management
  • Process and Cleaning Validation Programs and Executions
  • Automation / Computer Systems Validation
  • Document Development / Management
  • Quality Systems Development / Consultations
  • SOP Development
  • Audits / Assessments / Root Cause Analysis / Risk Assessments
  • Product Development / Technology Transfer / Process Validation