Practical Solutions

152 Witherspoon St
Princeton NJ 08542

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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