Aspiring Together for Therapeutics and Vaccines

AspireBio provided us with the Regulatory CMC support we needed to get our gene therapy IND over the finish line with the FDA. We are a small start-up working on an ultra-rare disease that needs fit-for-purpose solutions that strike the right balance between Regulatory guidance and what makes sense for an ultra-rare indication.  Aspire Bio helped us develop creative solutions that meet guidelines without making over the top commitments. We have always felt that the Aspire Bio consultants are fully embedded on our teams and work down in the trenches with us, helping us to design creative solutions to ultra-rare gene therapy problems.

AspireBio’s expertise has been invaluable, providing immense support in the establishment of our Quality Management System. Their strategic guidance and assistance have played a crucial role in preparing us for GMP manufacturing. Their flexibility and always-willing-to-help attitude has turned them into more than consultants and closer to an extension of our team.        

AspireBio has provided regulatory support for our Phase 1 and Phase 2 clinical trials of an inhaled COVID Vaccine. Our trials have benefited immensely from their expert knowledge in regulatory compliance and vaccine biotechnology. We have enjoyed a positive working relationship with AspireBio, whose staff demonstrate efficiency and professionalism in their work.

We used AspireBio to assist with assay qualification and found their staff to be knowledgeable and easy to work with, and at a good value. I would recommend their services to anyone starting out in the QC/analytics space as a great resource. Their leadership also went above and beyond in expediting some urgently needed work for which we are very grateful.