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. 

The scope of professional services that are provided by or offered out of each DPS office is governed by the professional and business licensing requirements of each individual state or jurisdiction in which the DPS is located and whether DPS has the requisite professional and business licenses for that State or jurisdiction.  Nothing on DPS’s website or marketing materials is intended to be interpreted or construed as offering to perform professional licensed services where prohibited unless the licensing requirements have been met.

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

Director, Strategic Consulting Group

Aidan Harrington

Principal Consultant - CQV and Regulatory Affairs

Mike Gorman

Principal Consultant, Manufacturing Operations

John McGrath

Senior Quality Consultant

William Whitford

Life Science Strategic Solutions Leader

Request a speaker

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

Back to top