Progress-PME
Progress is an independent consultancy company specializing in the pharmaceutical, biotechnology, and healthcare sectors. Founded in 1999, it offers project management, engineering, CMC, validation, Lean/OPex, quality assurance, and feasibility studies services internationally. The company emphasizes teamwork, expertise, integrity, and flexibility to help clients achieve their goals in drug development, manufacturing, regulatory compliance, and project viability.
Industries
Nr. of Employees
medium (51-250)
Progress-PME
Hoofddorp, Noord-Holland, The Netherlands, Europe
Services
Tailored consultancy for facility design, CMC strategy, quality systems, ATMP manufacturing and specialised topics such as viral validation and extractables & leachables.
End-to-end project management from feasibility and detailed engineering to construction supervision, contractor selection, permits and post-commissioning support to deliver compliant GMP facilities.
Full CQV program delivery including requirements capture, design qualification, protocol development, test execution and reporting for facilities, utilities, equipment and automated systems.
Analytical method development, qualification and validation; bioanalytical study oversight; CRO selection, auditing and project management for bioanalysis.
Design and execution of audit programs, mock inspections, supplier audits and on-the-job training to prepare for regulatory inspections and remediate findings.
Risk assessment, protocol development, worst-case testing, operator training and continuous verification for cleaning validation programs.
Tailored consultancy for facility design, CMC strategy, quality systems, ATMP manufacturing and specialised topics such as viral validation and extractables & leachables.
End-to-end project management from feasibility and detailed engineering to construction supervision, contractor selection, permits and post-commissioning support to deliver compliant GMP facilities.
Full CQV program delivery including requirements capture, design qualification, protocol development, test execution and reporting for facilities, utilities, equipment and automated systems.
Analytical method development, qualification and validation; bioanalytical study oversight; CRO selection, auditing and project management for bioanalysis.
Design and execution of audit programs, mock inspections, supplier audits and on-the-job training to prepare for regulatory inspections and remediate findings.
Risk assessment, protocol development, worst-case testing, operator training and continuous verification for cleaning validation programs.
Expertise Areas
- Commissioning, Qualification & Validation (CQV)
- Process validation and Continued Process Verification (CPV)
- CMC development and regulatory dossier support
- MSAT / ASAT and process optimisation
Key Technologies
- LIMS / ERP / MES / EMS
- Statistical Process Control (SPC)
- Liquid chromatography–mass spectrometry (LC‑MS)
- Bioreactors and single-use bioprocessing systems
News & Updates
Celebration of Progress's 25th anniversary with networking, reflection, and a guest speaker in Noordwijk on October 10.
Annual event organized by Progress focusing on advanced therapy medicinal products.
An overview of regulations and compliance in radiopharmaceuticals.
Insights into the responsibilities and importance of Qualified Persons in pharma.
Discussion on how cultural differences affect pharmaceutical and biotech projects.
Celebration of Progress's 25th anniversary with networking, reflection, and a guest speaker in Noordwijk on October 10.
Annual event organized by Progress focusing on advanced therapy medicinal products.
An overview of regulations and compliance in radiopharmaceuticals.
Insights into the responsibilities and importance of Qualified Persons in pharma.
Discussion on how cultural differences affect pharmaceutical and biotech projects.