Who We Are

Our mission is to provide state of the art, best in class, process engineering solutions and services to the biopharmaceutical and medical device industries.

Our Story

“While most engineering firms talk about focusing on what is critical—product quality and patient safety, PDS has invested in technology and innovation to drive our core business. For over 10 years, Quality by Design and its concepts, have driven our values and our business. We’ve integrated technology to help us and our customers deliver projects Right First Time.”

—Paul Stanovich, Managing Partner      



Our Values

As trusted advisers, we strive to provide the highest possible value in everything we do.

This means we ensure…
Quality in what we deliver, first and foremost
Value that exceeds our customers expectations
Integrity which is demonstrated every day

Our Approach

Our unique approach applies the concepts of QbD to improve all aspects of the process engineering function.

Our innovative solutions combined with deep subject matter expertise help companies deliver projects right the first time.


How We Do This

Listen. Plan. Deliver. By strategically focusing design efforts on product quality and patient safety, we extend the principles of QbD into the process engineering space for manufacturing systems, helping clients appropriately apply the principles of...

Quality Risk Management (QRM) via ICH Q9
Engineering Change Management (ECM) as a supporting process
Quality Systems (QS) to manage impact to critical aspects


Quality by Design (QbD, ICH Q8) is the systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.

Listen. Plan. Deliver. Success By Design.

Services

PDS is a trusted partner providing clients expertise in:

  • Process Engineering
  • Automation
  • Engineering Knowledge Management
  • Project Management
  • Program Management
  • Single-Use & Material Qualification

Process engineering in all phases for new, existing and multi-product facilities.

  • Front End Engineering Design (FEED)
  • Conceptual, Basic, & Detail Design
  • Tech Transfer & Facility Fit
  • Process Optimization
  • Engineering Project Support

Automation engineering in all phases for new, existing and multi-product facilities.

  • Control System Conceptual Design
  • Control System Specification, Design, & Implementation
  • Test-bed Development & Implementation
  • Computerized Systems Validation
  • Alarm Design & Rationalization

Driving greater efficiency for our clients in how they manage and generate engineering deliverables to support operations and engineering change management.

  • Electronic Process Descriptions (ePDs)
  • PFDs, P&IDs
  • System Requirements URS
  • Design Specifications FS, CS, etc.
  • Equipment/Component Data Sheets
  • Single-use Component Drawings
  • Facility Fit Assessments
  • Design Reviews/Risk Assessments

Project controls to effectively manage their critical projects from conception through closure.

PDS partners both with clients and third party Providers to effectively manage project teams and project controls.

Our client’s projects range in scope and complexity however we treat each project by listening, planning, and delivering what is expected.

All phases of planning and implementing ASTM E2500 to manage all elements of the engineering and operational phases of the manufacturing system lifecycle and QbD.

  • ASTM E2500 Planning & Implementation
  • QRM Program Development & Implementation
  • Change Management
  • Design Review & Risk Assessment
  • QRM Consulting and Training

All single-use and material qualification activities.

  • Single-Use Program Development & Implementation
  • Requirements & Specifications
  • Leachables & Extractables Assessments
  • Component Failure Evaluation & Risk Assessment
  • Material Qualification Consulting & Training

Clients