Veristat can provide its regulatory submission expertise both in the US and abroad. We can assist you in achieving regulatory approval with our team of experienced medical writers and strategic consultants.
When Veristat partnered with a US based biotechnology company on a Phase II study for a topical spray to treat hypertension, our emphasis on effective planning and management led to overwhelming success.
View our FDA Meeting Types Infographic to learn about Type A, Type B and Type C meetings – with specific insights into meeting timing, purposes and examples of each type throughout development.
A clinical stage biotech firm engaged Veristat to run their very first ever clinical trial, a phase I US only oncology trial. When the project started, the client was a three-person team. Veristat was and still is the entire project team and we have and continue to work with this client to guide them and train them through the clinical trial process.
Veristat's hematology experience spans clinical development consulting, full clinical trial oversight, and regulatory submission preparation for rare genetic blood disorders and autoimmune blood diseases as well as blood cancers.
View the presentation slides from our June 13, 2019 webinar. In this presentation, you will learn about the value and types of FDA meetings, how to write your questions for FDA, what to include in your briefing package and how to prepare for your actual meeting.
Watch our webinar to learn about the value and types of FDA meetings, how to write your questions for FDA, what to include in your briefing package and how to prepare for your actual FDA meeting.
Webinar Video Replay
A poster presented by Gillian Birnie, Senior Director of Corporate Compliance
at the Society of Quailty Assurance (SQA) Annual Meeting 2018.
Implementing an electronic Trial Master File (eTMF) isn’t as simple as it sounds.
Infectious Diseases have a global presence that has evolved with humanity for centuries. For many of these diseases, if they are not controlled, they will turn lethal.
Read more about our experience in infectious disease trials, and how Veristat can support you in your next clinical trial.