Ellen Smedts is a seasoned Regulatory Affairs consultant at E.J.L. ExAct, where she leverages her extensive expertise to navigate the complexities of the ever-evolving regulatory landscape in the pharmaceutical industry. With a strong focus on both human and veterinary medicinal products, Ellen specializes in European...
Ellen Smedts is a seasoned Regulatory Affairs consultant at E.J.L. ExAct, where she leverages her extensive expertise to navigate the complexities of the ever-evolving regulatory landscape in the pharmaceutical industry. With a strong focus on both human and veterinary medicinal products, Ellen specializes in European and national marketing authorization procedures, ensuring that her clients meet the stringent requirements set forth by regulatory authorities. Her commitment to high-quality standards and meticulous attention to detail allows her to provide invaluable support to pharmaceutical companies, enhancing their regulatory operations and facilitating smoother submissions.
Currently, Ellen is involved in several key projects that aim to streamline regulatory submissions and improve compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP). She is adept at developing and implementing robust quality systems and standard operating procedures (SOPs) that not only meet regulatory expectations but also promote operational efficiency. Her proficiency in Chemistry, Manufacturing, and Controls (CMC) further strengthens her ability to guide clients through the intricacies of product development and lifecycle management.
Ellen's collaborative approach fosters strong partnerships with her clients, empowering them to navigate challenges and seize opportunities in the regulatory arena. By staying abreast of the latest industry trends and regulatory changes, she ensures that her clients are well-prepared to adapt and thrive in a dynamic environment. Her passion for regulatory affairs, combined with her comprehensive skill set, positions her as a trusted advisor for pharmaceutical companies seeking to enhance their regulatory strategies and achieve successful market access. For more information about her work and expertise, visit www.ejl-exact.com.
