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Progress Project Management & Engineering (Progress-PME)

Progress Project Management & Engineering (Progress-PME) is an independent consultancy and management company offering services to customers in the pharmaceutical and biotechnology industries and in the healthcare sector.

Progress-PME operates internationally, supplying project management, engineering, Commissioning & Qualification, CMC (process development and validation through regulatory registration including technology transfer), Lean/Operational Excellence and Quality (QA, QP, QC) services to biotech, pharmaceutical, life science and healthcare industries.

Operational Services

Progress-PME’s mission is to excel in supporting clients in bringing new drugs to market and to deliver more effective affordable healthcare. This involves helping clients realize their business goals by harnessing Progress-PME’s in-depth knowledge and experience, combined with focus and flexibility to assure success of high value services and projects and multi-disciplinary progress.

To these ends, Progress-PME offers general services in the following fields:

  • Project Management: Specialized management for pharmaceutical and biotech companies, delivered by experienced project managers combining in-depth knowledge of pharmaceuticals and biotech products and processes with excellent project management and communication skills. Project managers are Prince-2 certified and have often followed a lean Six Sigma training to Green Belt or Black Belt standard.

  • Consultancy: Consultancy services are provided in all listed areas of expertise and can be performed on an ad-hoc basis as part of a long-term consultancy contract or for a dedicated subject in a specified time period.

  • Quick scan & GAP analysis: a specialized service that helps companies assess particular risks involved with such questions as entry to new markets, facilities inspection, or bringing new drugs to market. The service uses proprietary GAP analysis or Quickscan tools that quickly bring essential information to decision makers to assess business risks, prioritize business needs and identify gaps in preparedness, validation, training, etc. This service is jointly provided with Progress-EXS , the high level consultancy arm of Progress-PME.

  • Training: Expert courses focused on relevant target groups and covering such areas as GMP compliance and validations, microbiology and aseptic preparations, Good Laboratory Practice (GLP), GMP for project managers and technical maintenance personnel, as well as specific (technical) subjects such as freeze drying, Technology Transfer (TT), Quality by Design (QbD), Design of Experiments (DoE) and Root Cause Analysis.

  • Hospital Pharmacy: Expert support to hospital and/or pharmacy teams in preparing and distributing drugs to GMP-Z respectively GMP standards, along with personnel, regulatory, quality, inspection and operational aspects.

  • Biobanking: Harnessing Progress-PME experience in design, roll-out and optimizing quality systems based on risk evaluation to ensure high quality and safe biobanks (repositories of privacy-sensitive data and patient samples) to ensure uniform research with reliable and reproducible results, higher confidence in results, greater cooperation and lower costs with minimized operational risks.

  • Temperature mapping: Validating, monitoring and optimizing warehouse and temperature-controlled environments to comply with GMP guidelines for safe storage of temperature sensitive pharmaceutical products (via our partner Valcom).

Management Services

Progress-PME also offers a range of specialized services to help clients with interim management and strategic aspects of the business. These include:

  • Quality management: Ensuring full compliance with regulations and guidelines, taking in Quality Assurance (QA), Quality control (QC), Auditing, Quality Improvement and detailed GxP knowledge ad gap analysis.

  • Lean Six Sigma: Enabling organizations to improve performance, harnessing active commitment of employees, by merging the disciplines of lean manufacturing and six sigma analysis. Progress-PME’s green belt or black belt certified specialists and project managers use Lean Six Sigma concepts to simplify processes, reduce variation and increase personnel engagement, taking in operational excellence, project management and root cause investigation.

  • Chemistry Manufacturing and Control: CMC services from Progress-PME encompass the development, testing, documentation and registration of new pharmaceutical products, together with production and associated aspects, including analytical method development and validation, stability studies strategy, process development and Process Performance Qualification (PPQ), QbD, Quality Risk Management (QRM) implementation, TT and continued process verification (CPV) using Statistical Process Control (SPC).

  • Engineering and Facilities: Expert support for the whole life cycle of manufacturing plants and laboratories in the (bio) pharmaceutical industry and healthcare sectors, taking in aspects of feasibility studies, engineering, project review, second opinion, construction management, commissioning, validation, cleaning and decommissioning compliance.

Company history and structure

Progress-PME was founded in 1999 by pharmaceutical production specialist Paul Linssen with Saskia Vreeman to meet the growing need for expert specialized consultancy in the pharma and biotech field. It operates internationally, as an independent consultancy company, supplying customers in the pharmaceutical, biotechnology and healthcare sectors with project management, interim management, engineering, CMC, validation Lean/OPex and quality assurance services.

Its subsidiary company, Progress-EXS provides interim senior management and consultancy services to the life sciences and pharmaceutical industries (see separate supplier pages for Progress-EXS).

Under founder Paul Linssen’s leadership Progress-PME has grown to become an about 50-strong team. The current management team includes Octaaf Bos as Chief Executive Officer (CEO), Edwin van den Bos (Chief Commercial Officer) and Oscar Smit as Chief Operations Officer (COO).

Progress-PME is a private limited company with all the shares in the hands of the members of the Management board to guarantees maximum involvement of stakeholders in the company’s daily business.

Quality, Regulatory and Standards

Since Progress-PME clients need to comply with various international standards, all its consultants are well versed in these standards, including cGMP, EMA/FDA guidelines and specialized quality guidelines for biotech, pharma and hospitals.

The company is fully certified to ISO 9001:2015 quality standards and all staff are trained in cGMP and in Prince2. Many staff are trained In LSS to green belt or black belt standards.

Contact

To learn more about Project-PME services and capabilities and how they can assist your business, please the supplier.



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