Executing projects such as engineering and qualification of a new facility, preparing a new (bio-)pharmaceutical product for regulatory submission, or upgrading your Quality Management System are typical projects that you may not undertake annually. Furthermore, efforts to prepare for an inspection by the United States Food and Drug Administration (FDA) require all the assets of effective Project Management. Hiring external staff to lead and/or support these projects may therefore be necessary due to:

• Lack of specific knowledge and experience with similar projects
• Lack of capacity to implement the project(s) in parallel with your ongoing activities
• The need to reduce time-to-market or accelerate other milestones by providing additional staff or expert knowledge for your high-priority project(s)

Whatever the reason, Progress can provide you with customized project/program management to lead your project(s) from start to finish, or for shorter project periods. Our project managers are PRINCE2 certified and will use these tools where appropriate for your project. Our consultants combine advanced project management skills with a hands-on mentality and a strong technical background in one or more Progress areas of expertise; Engineering and Commissioning & Qualification, CMC, and Quality.

Depending on your needs, the focus is on project management services, for example leading the project team, ensuring timelines and deliverables are met, securing scope and budget, and managing stakeholders. When requested and where needed, the consultant will also contribute his/her technical expertise to the project. Our consultants have extensive experience with diverse teams in both small companies and international organizations.

Progress consultants fit easily into any organization to collaborate effectively and share their (technical) knowledge for the best project results

We can support you in the following project roles:

• Program manager
• Project manager
• (Sub)Project team lead
• Project manager assistance (PMO support)
• Project advisor on specific strategic or operational aspects
• Project team members, such as SMEs and/or representatives from Engineering, Validation, Analytical Development, Process Development, MSAT, ASAT, Manufacturing, QC or RA departments
• QA project officer who ensures adherence to project deliverables

Examples of typical projects that our project managers have executed are:

• Feasibility and basic design studies
• Commissioning and Qualification of new or upgraded facilities and utilities or specific equipment such as filling lines, freeze dryers, autoclaves, fermenters, etc.
• CMC projects from early stage through to regulatory submission
• Technological Transfer projects (both analytical methods and process transfer)
• Implementation of a new Quality Management System in accordance with the ICH guideline: Q10 Guideline.pdf (ich.org)

Because projects can take several years from initiation to completion, our project managers and/or team members remain available throughout the entire duration, as well as the aftercare period. Where necessary, we can also contribute to your project for a shorter period, for example by conducting a risk assessment and/or a design review.

Project review and second opinion

Have you conducted or had a Basic Engineering project conducted, but are you wondering whether you are on the right track? Are you looking for a project review and second opinion? Then come and talk to Progress.

Our engineers can give you a realistic estimate of the required space use, but also of the required technology, routing, and logistics. With our knowledge and experience and the information you provide, we can quickly advise you in writing about the budget, scope, and planning of your project. If desired, we can work out an alternative plan for you.

We also offer Consultancy, Interim Management and Temporary Staffing services.