Welcome to eCTD Submit

Customer-focused regulatory submission services

Alice Bexon
Co-founder and Chief Medical Officer

Alice is a 25+-year veteran drug developer who trained as an MD in the UK then worked as an oncologist in France. She has worked for co-operative groups, CROs, global pharmaceutical companies and biotechs. Along with a wide-ranging knowledge of clinical development and medical marketing, Alice has extensive regulatory experience interacting with bodies such as the FDA and EMA. Her team of MDs, scientists and writers are experts in writing and reviewing regulatory submissions worldwide.

Pete Minnick
Co-founder and Vice President of Regulatory Operations

One of the top eCTD experts and thought leaders in the industry today, Pete runs our publishing team with a deep understanding of regulatory and pharmaceutical standards that has shaped the thousands of original filings and hundreds of thousands of eCTD sequences in which he’s been involved, either through hands-on publishing or managing a global team.

Mike Yefimenko
Co-founder and Vice President of Regulatory Affairs

As an accomplished regulatory expert with a broad grasp of clinical, non-clinical and manufacturing requirements, Mike’s 20+-year career in regulatory affairs encompasses major pharmaceutical companies, CROs, medical device manufacturers and combination product companies. In addition to his extensive regulatory knowledge, Mike has a long history of personal interactions with regulatory bodies such as the FDA, EMA, rapporteurs and notified bodies, including broad experience preparing for (and passing!) regulatory inspections.

Tim Reid
Co-founder and Head of Technology

Tim’s financial and risk management expertise was forged on Wall Street and the Paris Bourse, where he led software development teams focused on risk modeling and management. However, in eCTD Submit Tim returns to his origins in the life sciences—he began as a research scientist studying the underlying mechanisms of metastatic cancer in Japan, France, the Netherlands, and the UK. Now, Tim brings his unique experience to bear ensuring good value and security for our clients.