📍 152 Witherspoon St, Princeton, NJ, 08542
📞 609-683-0756
Operating at both the strategic and tactical levels, The Practical Solutions Group, LLC works with domestic and international life science companies and their outsource providers (e.g., CROs, software companies, CMOs, manufacturing facilities, distribution centers, laboratories, packaging facilities) to integrate the principles of business operations and quality assurance/regulatory compliance. Our approach helps to identify underlying business problems and risk factors that may eventually stifle growth and negatively affect profits. The value of our advice, assessments and deliverables rises to the level of the big management consulting names but at a much more affordable rate. Our core expertise includes, but is not limited to, the following: - Selecting and managing outsource partners: demonstrated success with predicting potential operational/regulatory compliance issues with prospective outsource partners and remedying existing ones - Developing/simplifying the quality infrastructure and business processes: demonstrated success in helping clients to achieve and maintain regulatory compliance without increasing costs, expanding timelines and/or adding resources; includes serving as a part-time quality assurance function until the company needs/can afford a full-time group - Performing high-quality audits, due diligence and assessments: demonstrated added value through performing mock FDA inspections, and auditing/assessing manufacturing operations, labeling/packaging operations, distribution operations, laboratory operations, system validation, etc. - Assisting with computer system validation: demonstrated creativity in achieving the 21 CFR part 11 compliance with less effort
📍 20 Abeel Rd, Monroe Township, NJ, 08831
📞 609-495-8032
📍 11 Deerpark Dr, Monmouth Junction, NJ, 08852
📞 732-230-3335
📍 2 Research Way Ste 102, Princeton, NJ, 08540
📞 609-454-3697
📍 7 Wheeling Rd, Dayton, NJ, 08810
📞 732-997-4100
📍 1206 Cranbury S River Rd, Cranbury, NJ, 08512
📞 609-860-1803
🌐 www.pci-hplc.com
Locally owned and operated. See us for all your needs
📍 319 Ridge Rd, Dayton, NJ, 08810
📞 732-329-0514
📍 331 Herrod Blvd, Dayton, NJ, 08810
📞 732-274-0393
📍 6 Corn Rd, Dayton, NJ, 08810
📞 732-329-4626
📍 18 Thatcher Rd, Dayton, NJ, 08810
📞 609-655-4018