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DPS | Better Engineered Solutions

Better Engineered
Solutions

Strategic Consulting

About Us:

DPS Global Strategic Consulting Group helps biopharmaceutical clients develop the right solutions for their technology, engineering, operational, regulatory and quality needs. DPS’s differentiator is our team, made up of biopharmaceutical technology & facility specialists, experienced operational professionals, CQV and quality and regulatory compliance specialists who bring decades of first-hand industry experience to the table. We’ve run manufacturing sites, served in senior engineering and quality roles, and everything in between: so we know the demands of an everchanging industry inside out.

Services:

Facility pre-Concept Designs and Feasibility Studies Strategic Planning Facility Cost Benchmarking Technology Assessments Design Peer Reviews GxP Compliance; Facility Audits, PreInspection Readiness Quality System Remediation and Design Operational Excellence, Lean Six Sigma Project and Quality Risk Assessments

We help our clients to:

  • Consolidate ideas into best fit concept designs with accurate cost benchmarking;
  • Provide expert assessment of current and leading edge innovative technologies, regulatory and quality strategies;
  • Develop CQV, start up and PV strategies;
  • Support operational readiness and lean manufacturing;
  • Develop, streamline, remediate and implement Quality Systems for cGMP regulated companies;
  • Achieve Facility Registration;

Our Team:

  • Principal Consultant, Director DPS Strategic Consulting Group

    Sue Cooke. BSc.

    Principal Consultant, Director DPS Strategic Consulting Group

    Sue Cooke. BSc.

    Principal Consultant, Director DPS Strategic Consulting Group

    Sue is a Principal Biopharma Consultant and Director of the DPS Global Strategic Consulting Group. Sue has over 25 years’ experience in the Biopharmaceutical sector in Ireland, UK and mainland Europe engaged in Design Consultancy, Project and Program Management. Sue has a depth of experience in the early phase development of Biopharma projects leading feasibility and concept design studies for new facilities as well as extensive experience managing full design and construction project implementation. Her experience covers a broad range of facilities from laboratories, development and manufacturing facility projects in the drug substance and drug product areas, primarily for Biologics and ATMPs.

  • Principal Consultant - CQV and Regulatory Affairs

    Aidan Harrington. PhD

    Principal Consultant - CQV and Regulatory Affairs

    Aidan Harrington. PhD

    Principal Consultant - CQV and Regulatory Affairs

    Dr. Harrington is a Principal Consultant with DPS based in Ireland, who has been working in the Pharmaceutical Industry since 1992. Aidan has worked in QA, Validation and Engineering roles in both manufacturing and capital project environments for the pharmaceutical industry and is an expert in US FDA and EU cGMP regulations. He has extensive regulatory inspection exposure experience; EMA, FDA and HPRA. Aidan has played significant roles on the planning and implementation of Commissioning and Qualification programs for large capital projects including implementation of Quality Risk Management principles from concept design phases to product Process Validation for sterile and biologics drug substance manufacturing facilities. Aidan offers consultancy to a range of clients in areas such as concept design for cGMP compliance, risk reviews, inspection pre-audits, technology transfers, new technology assessments and contamination investigations.

  • Principal Consultant - Parenteral Manufacturing & Facility Design

    Barry Starkman

    Principal Consultant - Parenteral Manufacturing & Facility Design

    Barry Starkman

    Principal Consultant - Parenteral Manufacturing & Facility Design

    Barry Starkman is a Principal Consultant for parenteral manufacturing and facility design working from our Framingham, Boston office. Barry is a biopharmaceutical professional with over 30 years’ experience in large sterile manufacturing facility design, start up and operation and has held engineering and executive manufacturing leadership roles for Merck and Genentech in the USA. He has a unique mix of manufacturing, engineering and senior corporate leadership experiences which we believe provide real value and insight into the early phase design and implementation of sterile manufacturing facility projects and business processes. His experience includes vaccines and potent compounds. Barry was responsible for the development of the performance based exposure control limit program for potent pharmaceutical compounds at Merck. He was responsible for design and implementation of a number of significant high capacity state of the art, isolated sterile filling facilities for Merck and Genentech. Barry provides strategic planning, early project feasibility and pre-concept design consulting to DPS clients and internal teams in USA and EU as well as expert advice on operational excellence, lean design and operations and business improvements.

Request a Speaker

To discuss your requirements, contact us at Biopharma@dpsgroupglobal.com