Consultancy can be the solution for your situation. For example, when you are considering building your own GMP facility or launching your first (bio-)pharmaceutical product or expanding your product portfolio with a new type of product, you may lack certain essential knowledge. When you need to act quickly to prevent delays, or when only temporary advice is needed on a specific topic, or when you want a second opinion, hiring a consultant can be a good option.

Our consultants have numerous years of experience in various roles in the life science industry, mainly in (bio-)pharmaceutical and/or medical devices. Over the course of their careers and as consultants, they have acquired extensive knowledge in the areas of CMC and MSAT, Quality, Engineering and CQV, and ATMP. Within our team of consultants we also have experts in certain niche topics, such as Virus Validation, Cleaning Validation, Extractables and Leachables.

Our consultants are results-oriented and use and share their extensive knowledge and broad experience to accelerate your projects. We believe that good consultancy does not only mean advice on improving and/or implementing a new process or system. A good consultant collaborates with the client to realize the implementation and shares his/her knowledge with the client’s employees. Core competencies of our consultants are flexibility, listening, planning, and taking initiative to achieve the best results for our clients.

Our services are tailor-made. Depending on the wishes of the client, a consultant assignment can vary from just a few hours for a specific and short request, to a long-term working relationship between one or more of our consultants with the client.

Examples of typical consultancy assignments are:

• Advice on green of brownfield options for building a new facility by detailing the pros and cons of both options
• Advice on scale-up issues and/or relocation of processes and equipment within an existing GMP facility
• Advice in CMC projects, for example consultation on preparing validation strategies, preparing Type B or C regulatory meetings, setting up development plans in accordance with QbD principles, preparing contamination control strategies, defining, and implementing cleaning validation strategies
• Advice on new design or upgrade of Quality Management Systems and their implementation

We have developed various Quick Scans to assess the status of your Quality Management System, your facility, and/or your CMC project(s) in just a few days. Our consultants give you a clear overview of the areas that are under control and the areas that require attention and/or immediate action to maintain your license to operate and/or ensure that planned milestones can be achieved. Examples of our Quick Scans are in the areas of Extractables & Leachables, Process Validation/PPQ, Regulatory Affairs, Quality Control and Lean Six Sigma.

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