Consulting

Where is the bottleneck in your manufacturing? What could an upgrade of ongoing production for new products look like—without jeopardizing compliance? We support you in clarifying regulatory requirements and implementing them in a practical manner in planning and execution. In doing so, we do not only address classic GMP topics, but analyze your project holistically—technically, organizationally, and economically. Our scope of services includes, among other things:

We analyze your existing processes holistically—from material and personnel flows to equipment capacities, utility consumption, and organizational interfaces. On this basis, we identify bottlenecks, assess optimization potential, and develop realistic, implementable measures. Our focus is on cost-effective solutions that increase productivity, reduce lead times, and reliably meet regulatory requirements.

After clarifying all user requirements and developing robust space concepts, we support you in evaluating suitable sites. As part of technical and regulatory due diligence reviews, we analyze existing properties, infrastructures, and utility supply systems for their suitability for your specific processes. In doing so, we consider investment requirements, expansion options, approvability, and risks with regard to GMP compliance.

We support you in the strategic development and expansion of your production sites—as well as in disentangling historically grown structures. Whether GMP manufacturing areas, administration, warehouse and logistics areas, central technical facilities, or traffic and access areas:

Is the integration of a new production area permissible from a regulatory perspective and technically feasible? How long is the project likely to take? What investment costs can realistically be expected? We have been supporting our customers for many years with well-founded feasibility studies for questions such as these. We analyze technical, regulatory, and economic conditions, assess risks, and develop robust scenarios.

In the area of quality management, we provide comprehensive support to ensure and further develop your GMP-compliant structures. Our approach is practical, risk-based, and geared toward sustainable compliance. Our range of services includes, among other things:

• Support in establishing and maintaining a GMP-compliant quality management system
• Preparation, review, and regular updating of GMP-relevant documents and SOPs
• Planning and support of validations (process, cleaning, computer, and method validation)
• Preparation, execution, and follow-up of internal and external GMP audits as well as regulatory inspections

Through our experience as a general planner for GMP facilities as well as a general contractor under various contract models, we have in-depth market and project expertise. Based on completed projects, we are able to realistically budget investment and project costs even in early project phases and benchmark them against comparable projects.