At AspireBio Consulting, we are dedicated to supporting pharmaceutical and biotechnology companies from early-stage research through to successful market launch. With a proven track record and deep expertise in pre-clinical/non-clinical development, Chemistry, Manufacturing, and Controls (CMC), quality assurance, and regulatory compliance, we ensure your products meet the highest standards set by major regulatory bodies including the FDA, Health Canada, and the European Medicines Agency (EMA).
Our team is led by Sarmitha (Sam) Sathiamoorthy, President and Principal Consultant, who brings over 15 years of experience in the biopharmaceutical and medical device industry. With expertise in vaccines, immuno-oncology, cell and gene therapy, and diagnostics. As a passionate and innovative leader, Sam bridges the gap between science and business, helping clients navigate the complexities of product development.
At AspireBio Consulting, we are committed to excellence in every project we undertake. We provide tailored solutions to meet the unique challenges of your product development lifecycle. Whether you are navigating the complexities of CMC, quality control, regulatory management, technical writing, vendor management, comparability, analytical testing and market research.
We are here to propel your projects forward and turn innovative concepts into market-ready solutions. Let AspireBio Consulting be your partner in navigating the path from bench to bedside, leveraging our comprehensive services to ensure your product not only reaches the market but also thrives against the competition.