Clients & Partners

Our clients have included small to medium-sized biotech and pharmaceutical companies based around the world in countries such as the US, France, The Netherlands, Germany, Australia, Israel, Canada and the UK. These companies tend to have a few things in common: they develop medicines for serious, life-threatening conditions, they have a need for custom regulatory strategies and exceptional writing support, and they highly value experience and expertise.

“We have used the services of RegResponse extensively over the last couple of years for the completion of our first major MAA filing to the EMA.  Bonnie helped us to develop a sound regulatory filing strategy, led the Team to successfully complete the MAA filing on time, and expertly guided us through the demanding EMA review process. Bonnie’s in-depth regulatory knowledge, excellent leadership and organizational skills, as well as her commitment to meeting deadlines were invaluable to our Nektar Team.  Bonnie and Kathleen’s exceptional writing skills contributed to the creation of very high quality submission documents. Both Bonnie and Kathleen live-up to the company’s triple E motto – Excellence, Efficiency, Expertise – and both are passionate about bringing new medicines to patients. I wholeheartedly recommend their services.” – Carlo Di Fonzo, Senior VP, Drug Development & Regulatory Affairs, Nektar Therapeutics

“ProQR used several of the services of RegResponse over the years for our regulatory strategy and execution. Bonnie’s exceptional leadership, Kathleen’s medical writing, and their team’s expertise and efficiency, lead to significant added value and some great accomplishments together.” – Daniel de Boer, CEO, ProQR Therapeutics NV

“We used RegResponse in a European Submission, in which a complete filing was compiled in very short time. The customer appreciated the expertise, leadership and focus provided by RegResponse. We would always work with Bonnie’s team again, and recommend her fully.”– Thomas Hoffmann, CEO Aumapharma Inc.

Based on project needs, we partner with other trusted and experienced consultancy firms to ensure the best possible outcome for client’s projects. We have long-standing, tested relationships with these firms and can count on them when their skills are needed to complete a project.