Sam Sathiamoorthy established AspireBio Consulting as a boutique consulting firm specializing in vaccines, cell and gene therapy and biotherapeutics. She has over 15 years of experience in large pharmaceutical companies, biotech start-ups and early stage proof-of-concept environments. Sam is an expert in GMP/GLP compliant spaces with products under the purview of FDA, EMA and Health Canada.
AspireBio Consulting has over 12+ individuals, most holding Ph.Ds in their field, with areas of expertise including, CMC technical support, CMC regulatory strategy, quality, technical and regulatory writing, supply chain and procurement and conducting technology assessments and due diligence activities. To date, AspireBio Consulting has supported over 30 clients ranging from proof-of-concept to mature biotech/pharmaceutical companies. The work has included technical writing, regulatory strategy/writing to support submissions (INTERACT, pIND, IND, BLA), market research, supply chain risk assessment and procurement support, technology assessments, QMS set-up, auditing and remediation support and CMC technical support (analytical development, process development, manufacturing, quality control and stability)
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