When your company is moving into a new phase, e.g., considering building your own GMP facility or launching your first (bio-)pharmaceutical product, or extending your product portfolio with a new type of product, you may lack certain essential knowledge to proceed.
When you need to move fast to prevent delays, or when only temporarily advice on a specific topic is needed, or when you would like a second opinion, hiring a consultant can be a good option.
Our consultants have multiple years of experience in various roles in the life science industry, primarily in biotech, ATMP, pharmaceutical and/or medical devices. In the course of their careers and as consultants they have gained extensive knowledge in the fields of Engineering and Commissioning & Qualification, CMC development and regulatory submission, and Quality & Compliance. Within our team of consultants we also have experts on certain niche topics, such as Virus validation, Cleaning validation, Extractables and Leachables. View ourservices to see all the topics we can provide expert knowledge in.
Our consultants are results driven and utilize and share their extensive knowledge and broad experience to accelerate your projects. We believe that a good consultant does not only give advice on how to improve and/or implement a new process or system; a good consultant works together with the customer to realize the implementation and shares their knowledge with the customer’s staff in the process. Key competences of our consultants include flexibility, listening, planning and taking initiative to deliver the best results for our customers.
Depending on the client’s wishes, a consultant assignment can vary from only a few hours in case of a specific and short inquiry, to a long-term working relationship between one or more of our consultants with the client where we provide consultancy services on an as-needed basis.
Some examples of typical consultancy assignments are:
- Advice on green of brownfield options for building a new facility by detailing the pro’s and con’s of both options
- Advice on up-scaling issues and/or relocation of processes and equipment within an existing GMP facility
- Advice in CMC projects e.g., consultations on drafting validation strategies, preparing for Type B or C regulatory meetings, setting up development plans in line with QbD principles, preparing contamination control strategies, defining and implementing cleaning validation strategies, etc.
- Advice on new design or upgrade of Quality Management Systems and implementation thereof
We have developed several quick scans to assess the status of your quality management system, your facility and/or your CMC project(s) in only a few days. Our consultants will present you with a clear overview of the parts that are under control and those that need attention and/or direct action to maintain your license to operate and/or to ensure that planned milestones can be met. An overview of all of our quickscans is given here.