As a chemist, I enjoy the chemical aspects of the pharmaceutical registration dossier, usually referred to as Module 3 (Quality / Chemistry Manufacturing and Control (CMC)), but over the years I have also worked with the other modules of the registration dossier.
CMC is where my passion for pharmaceutical compliance began 22 years ago. I enjoy writing dossiers, studying and implementing new regulations and achieving results in the form of obtained licenses and maintaining regulatory compliance. I enjoy working with regulations, and I experience a flow when writing dossiers. I have expanded my experience in license management over the years, initially primarily within the pharmaceutical industry in the field of Regulatory Affairs, and later also with Quality Assurance - through quality training and work experience on the interface of both RA and QA and in roles solely focused on QA.
Over time, I also began supporting related sectors in healthcare, such as the polymer industry regarding packaging, e.g., blood bags and medical devices. I broadened my perspective on business management by pursuing an executive MBA focusing on business psychology and corporate spirituality.
I am also a certified holistic coach and therapist; I love people and want nothing more than to bring out the best in them.
I support companies not only with regulatory compliance issues but also increasingly as a coach for junior field staff and senior management, individually or in teams within Regulatory Affairs & Quality Assurance. Additionally, should you need help restructuring your compliance department or exploring a new departmental idea, I can also support you as a project manager or conceptualizing the idea in the pre-project phase with all stakeholders. I am a creative thinker who likes to propose and implement strategies for change and improvement as pragmatically as possible.
I would be happy to help you!
Birke Geurts MSc MBA
Director GPS-Geurts Project Support (GPS)
Regulatory Affairs
GPS is dedicated to support pharmaceutical and chemical regulatory compliance throughout the lifecycle of your pharmaceutical and healthcare products.
GPS has a broad experience with regulatory procedures and holds good contacts with Health Authorities worldwide. GPS is experienced in obtaining pharmaceutical licenses (MAA’s) and managing the regulatory lifecycle for pharmaceutical innovative products as well as generics and subsequent product dossier lifecycle management, including module 1 to 3 writing.
Leadership support
GPS provides support to (young) senior managers or heads of office in the compliance roles, as a sparring partner in times of organizational change, departmental restructuring, temporary overload or to help grow and coach compliance teams.
Business Consulting and Strategic Advice
GPS has experience in quartering and providing strategic advice regarding feasibility of new ideas, i.e. acquiring or developing new products, but also departmental restructuring and the organisation of a (local and global) quality assurance / regulatory affairs department.