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Strategic Consulting

Our Approach

Clients trust DPS to help them make smarter strategic decisions, run lean and efficient operations and meet every cGMP compliance and regulatory challenge successfully.

DPS’s differentiator is our team who know the demands of an ever-changing industry inside out, made up of biopharmaceutical technology and facility specialists, experienced operational professionals, CQV and quality and regulatory compliance specialists. We’re specialists in sterile manufacturing, bulk biologics, ATMPs, vaccines, oral dosage, medical devices and combination products. 
 

How we help our clients

  • Achieve regulatory approval in North America, Europe and Asia.
  • Achieve facility readiness for pre-license/approval Inspections under a smart and compliant program.
  • Develop and remediate quality systems to ensure regulatory success.
  • Consolidate ideas into best fit cGMP concept designs with accurate cost benchmarking for informed board decisions.
  • Develop facility CQV, and PV strategies for faster, leaner project execution
  • Implement operational readiness and lean manufacturing strategies to reduce COGs.
  • Provide expert guidance on current and leading edge innovative technologies.
  • Get a solid foundation for strategic decisions on matters regarding supply chain, manufacturing, technology choices, and regulatory matters.
     

Our services

  • Quality system design
  • Facility audits; engineering and quality
  • Operational excellence, Lean Six Sigma, statistical analysis
  • Risk assessments
  • Technology assessments
  • Feasibility studies
  • Cost benchmarking
  • Design peer reviews
  • Technical consulting for strategic investments
  • Supply chain and manufacturing strategies
  • Tech transfer planning
  • Program management and owners alliance programs
     

Sue Cooke

Managing Director, Global Strategic Consulting

Helga Salling

VP Strategic Consulting

Stephanie Gaulding

Principal Consultant - Quality and Regulatory Affairs

Aidan Harrington

Principal Consultant - CQV and Regulatory Affairs

John Lewis

Process and Technology Director

Tim Vickers

Project Executive

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Clients trust DPS to engineer a difference. Connect with a DPS expert in your area today.

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