As the founder and Chief Scientific and Technical Officer of Qualigen, Inc., I have had the opportunity to work with numerous outside firms and consultants. For the past several years, we have utilized Mark's services on a variety of projects, from an IVD PMA submission to 510k's and manufacturing validations. Simply put, Mark is the best that I've worked with. His technical expertise, professionalism, attention to detail and timeliness are first rate. In 2007, Qualigen received FDA clearance for our FastPack® HCG Immunoassay. Mark prepared the 510k submission under an aggressive timeline. After we received clearance, the FDA Lead Reviewer told me, "This was the best 510k submission I've seen... very well done, thorough... the information is easy to find and understand... it was a pleasure to review..." Needless to say, I plan to utilize Mark's expertise on numerous future projects at Qualigen.
We have had the opportunity to work with the Vision Biotechnology team over the past 2 years on a number of different programs. We have found the staff to be talented, highly technically competent, and capable of providing support with a multi-disciplinary approach. VBC has worked with us on general regulatory issues relating to our in vitro diagnostic discovery and development programs, and have given us specific counsel and direction in our recent regulatory submission. In addition, they have provided highly sophisticated and technically demanding analytical and statistical support, and have trained our R&D staff in the principles of statistical experimental design. Finally, we have recently worked with the VBC staff to identify and secure access to several clinical and research studies for our biomarkers under development.
I have been constantly impressed by the responsiveness and coordination of this team. The work is done in a very timely and cost-effective fashion, with impeccable attention to accuracy, integrity and quality. They are particularly strong on follow-up and closure for all of their projects. I could not be more satisfied with the process and results of our interactions with VBC.
Eric Button (BioEmerge Partners Inc.) and I have enjoyed working with Mark Sarno and his partners at VBC on the regulatory affairs and other highly technically challenging tasks of our project to commercialize an in-vitro diagnostic assay for diabetes called GlycoMark. As a rather small and homey start-up team, enthusiasm and passion for getting things done right is eventually all we can give to the project, and that's exactly what Mark and his gang contributed the most to our pursuit. Thorough ongoing debate in search for more sound scientific observation that consequently leads us to a fit product characterization in the market is our tradition, and Mark has been integral to the process. We sure look forward to working with them as our project goes on.
Vision Biotechnology Consulting was contracted to assist us in solving some significant technical challenges we were experiencing with some of our manufacturing processes. Through the technical insight and experience of Mark Sarno and his associate Erich Blase we were able to overcome these technical challenges and save the company an estimated $160,000 within the first three to four months.
The broad range of technical knowledge and experience of the VBC staff was invaluable in approaching each issue. The guidance of Mark Sarno in applying statistical experimental design and analysis was key in allowing us to improve and validate our process parameters. We were pleased with the professionalism and responsiveness to our requests, and delighted with the outcome of this project. We will readily contact VBC to assist in other projects as they occur.
Mark Sarno of Vision Biotechnology Consulting has been contracted by Maxim on an extended basis to assist the company in a number of areas. His recent efforts in the areas of Manufacturing program management/counsel, Quality Assurance project management, Analytical Development, and Clinical study design and analysis have provided Maxim with excellent technical insights and recommendations as well as timely completion of much needed project related tasks critical to the company.