Smart Pharmaceutical Consulting (SPC) in an international consulting group specializing in supporting the life sciences industry. Managed by Nigel Smart, Ph.D and Christopher Macklin, SPC has over 30 years of experience in pharmaceuticals, biologics, medical devices, and other healthcare fields. SPC has offered support as a key FDA consulting advisor on compliance issues, with experience in virtual to fortune 500 companies, universities and government consulting. As experts in "Lean Biomanufacturing" SPC develops techniques for holistic and sustainable approaches by removing waste, simplifying redundant quality systems, reducing supply chain times (raw materials through distribution), increasing efficiency in laboratories, and assisting in developing company cultures that can identify future waste/inefficiency. SPC also assists in auditing, training, PAI preparation, FDA 483 responses/issue mitigation, warning letters, consent decrees, and company recalls. SPC associates have varied yet complimentary experiences throughout the supply chain with specialties in areas such as "Lean Manufacturing", GLP's, GCP's, GMP's, clinical trials, supplier/vendor approval programs, training, and other regulatory body agency requirements throughout the world. This includes regulatory compliance areas such as CMC and electronic filings. SPC has successfully assisted in the development of startup pharmaceutical, biologics, medical device, and other healthcare fields, by providing compliant consulting expertise in usage of lean laboratory space, equipment, material, and personnel flow. This also includes utilities such as purified/WFI systems, HVAC, compressed air, clean steam, and CIP/SIP systems. We have expertise in oral solid dosage forms, parenterals, liquids/creams/ointments (including sterile), biological products, vaccines, recombinant products, monoclonal antibodies, cell therapies, tissue engineered products and device-combo products.