Welcome to eCTD Submit

Customer-focused regulatory submission services

Alice

Alice Bexon, co-founder and Chief Medical Officer

Alice is veteran of the pharmaceutical and biotech industry with 20 years of experience. She trained in the UK and then worked as an oncologist in France. Alice has worked for co-operative groups, CROs, global pharmaceutical companies and biotech organizations. Along with a wide-ranging knowledge of clinical development and medical marketing, Alice has extensive experience of interacting with regulatory bodies such as the FDA and the EMA. Alice’s team of MDs, scientists and writers has extensive experience of writing and reviewing regulatory submissions worldwide.

Pete

Pete Minnick, co-founder and Vice President of Regulatory Operations

Either by hands-on publishing or managing a global team of publishers, Pete has been involved in hundreds of original filings and tens of thousands of eCTD sequences to multiple regional health authorities. With his strong comprehension of regulatory and pharmaceutical industry standards, and continued involvement in industry thought leadership initiatives, Pete is considered one of the industry’s top eCTD experts and also runs our publishing team.

Mike

Mike Yefimenko, co-founder and Vice President of Regulatory Affairs

Mike began a successful career in regulatory affairs over 15 years ago; culminating in the key leadership role he plays today. As an accomplished regulatory expert with a broad grasp of clinical, non-clinical and manufacturing requirements, he has worked for 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 a broad experience of preparing for and passing regulatory audit.

Tim

Tim Reid, co-founder and Chief Financial Officer

Tim started out as a research scientist studying the underlying mechanisms of metastatic cancer. After a career that took him from the UK, Japan, France and the Netherlands he changed tack to become software engineer. Tim worked for various financial institutions on the Paris Bourse and Wall Street, leading software development teams focused on risk modeling and management. In eCTD Submit Tim returns to his passion of the life sciences, bringing to bear his financial and risk management expertise, he is well placed to ensure good value for money for our clients.