Technical Project Management

Effective project management is critical to ensure that complex biotech and pharmaceutical facility projects are completed successfully, on time and within budget. The size and complexity of these projects warrants the oversight of technical and regulatory experts to not only ensure compliance with timelines and budgets, but more importantly with regulatory requirements. Our experts have both industry and regulatory experience allowing them to identify technical and regulatory issues that might otherwise compromise the success of your project.
Frequently, our clients are facing multiple challenges involved with launching a new product on an accelerated timeline without sufficiently trained staff dedicated to Project Management activities. This is especially problematic in the highly regulated pharmaceutical industry where the project completion can be severely delayed by critical oversight in a single key system.

Our experts have specific project experience relating to new facility designs which meet the expiations of regulatory agencies around the world as well as proven solutions to challenging areas where regulatory agencies appear to have contradictory requirements. We can offer practical, proven solutions to compliance issues through strategic involvement at the planning and design stage of a project, thereby avoiding costly facility modifications if these issues were identified late in a project.

Our Technical Project Management approach is also highly effective at coordinating the evaluation and implementation of manufacturing site transfer projects to Contract Manufacturers. Our approach includes spending time at third party manufacturing sites to identify problems and issues early on which could significantly affect the success of a tech transfer project. Our experts become an extension or your resources to effectively address temporary resource demands without having to hire additional permanent staff.

We can provide complete oversight to a project or simply supplement your staff at any stage of a project from initial project definition and scope development, conceptual design, detailed design, equipment selection to commissioning, qualification, validation and startup activities.

Our Technical Project Management support to your project provides unique opportunities to leverage in house resources to get products to market faster and at the lowest possible cost.