A results-oriented consulting firm specializing in fast-paced, biopharm and hi-tech start-ups & small to mid-sized enterprises. Highly skilled in quality, compliance, regulatory, and operations management, product & process development, scale-up, validation, manufacturing, and commercialization of large and small volume parenterals, biologics, blood-derived therapeutics, API's. Subject Matter Experts in the areas of quality, GMP compliance, operations and commercial scale facility design. Our team consists of experts in operations, quality, compliance, & regulatory management, manufacturing, capital projects, regulatory affairs, and GMP, GLP, GCP regulatory compliance. We provide consulting services based on in depth knowledge and thorough understanding of FDA, Health Canada, European, and Asian regulatory requirements and guidelines. Specialties: • Quality & Compliance, Operations management, Technical due diligence, Strategic planning, Business & organizational development, Product commercialization, Team building • Manufacturing, Facility design & management, GMP & ISO Quality systems, CMC regulatory support, Technology transfer, Process development & optimization, Downstream processing, Protein purification & separation, Aseptic operations • Project management, Process & facility design, Construction management, Contract manufacturing & outsourcing BioAcuity Consulting’s team brings strategic and practical expertise to emerging and existing, biotech, pharmaceuticals, and other life sciences organizations always with a results-oriented focus to meet our client's business objectives. Our understanding of the realities of the industry complexities enables us to help our clients make the right decisions while balancing business, scientific, and regulatory requirements.