Company profile

Smart Pharmaceutical Consulting (SPC)

"One source for outsource"​

Industry
Pharmaceutical Manufacturing
Employees
3
Headquarters
West Chester, Pennsylvania
Founded
2016
LinkedIn followers
217
Office locations
2

Smart Pharmaceutical Consulting (SPC) company summary

Smart Pharmaceutical Consulting (SPC) is a company in the Pharmaceutical Manufacturing industry, headquartered in West Chester, Pennsylvania, founded in 2016. On LinkedIn the company has around 3 employees and 217 followers. The company lists 2 office locations. Its listed specialties include biotech, pharmaceuticals, Lean Manufacturing, Consulting, Training.

What technology does Smart Pharmaceutical Consulting (SPC) use?

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About Smart Pharmaceutical Consulting (SPC)

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.

Specialties

biotechpharmaceuticalsLean ManufacturingConsultingTraininglean labslean laboratoriesconsultingconsultantsfdagxpglpgmpCQAClinical QAmedical devicecomplianceconsultancyNDABLANDCPAICBERCDERprocess validationiq/oq/pqGlobal QAMHRAproject managementBusiness DevelopmentSales and MarketingCBERmock PAIData Integrity

Where is Smart Pharmaceutical Consulting (SPC) located?

Smart Pharmaceutical Consulting (SPC) lists 2 office locations.

West Chester, Pennsylvania, USHQ
20 E Market St
Bloomfield, New Jersey, US
40 Brookdale Gardens

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Frequently asked questions about Smart Pharmaceutical Consulting (SPC)

What does Smart Pharmaceutical Consulting (SPC) do?

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.

How many employees does Smart Pharmaceutical Consulting (SPC) have?

Smart Pharmaceutical Consulting (SPC) has around 3 employees on LinkedIn.

Where is Smart Pharmaceutical Consulting (SPC) headquartered?

Smart Pharmaceutical Consulting (SPC) is headquartered in West Chester, Pennsylvania.

Where does Smart Pharmaceutical Consulting (SPC) have offices?

Smart Pharmaceutical Consulting (SPC) lists 2 office locations, including West Chester, Pennsylvania, US; Bloomfield, New Jersey, US.

When was Smart Pharmaceutical Consulting (SPC) founded?

Smart Pharmaceutical Consulting (SPC) was founded in 2016.

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