Practical Solutions: Consultants

	Regulatory Compliance Simplified. The Practical Solutions Group, LLC is the Accenture / KPMG / McKinsey for small and medium-sized pharma, biotech and medical device companies, and their outsource providers. The value of our advice, assessment and deliverables rises to the level of the big management consulting names but at a much more affordable rate. We provide strategic and tactical advice designed to help our clients to (1) integrate the principles of quality assurance/regulatory compliance and business operations and (2) achieve and maintain regulatory compliance without having to add staff, engage in non-productive activities or increase operating costs. Our view is that all regulatory compliance/quality trends, treated from a risk-based perspective encouraged by the FDA itself, are symptoms of operational problems. We focus on helping companies to avoid and/or remedy both. We, the partners of The Practical Solutions Group, are the "go-to" people when you are faced with regulatory compliance and operational challenges that require expertise, insight and character to resolve. Read More >

Practical Solutions for Regulatory and Operational Problems:
• Compliance (GLP, GCP, GMP)
• Quality Assurance / Quality
Control Assistance
• Computer System Validation /
21 CFR part 11
• 21 CFR part 820, ISO13485
• Outsource Management
• CMC Support
• Operational and Compliance
Audits, Vendor Assessments
and Due Diligence

"Practical Point"
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Practical Solutions Brings Value to Your Operations

We believe passionately in creating an environment which helps to improve operational efficiency and profitability while maintaining regulatory compliance.

Connect to client case studies detailing challenges we’ve faced, the practical solutions we recommended and results accomplished.

Our deliverables help company management not only to assess the status of regulatory compliance, but also promote the drawing of sound conclusions regarding the status of company operations (e.g., ineffective department staffing, inefficient processes, inadequate contractual agreements). We become especially valuable when a company has a crisis where decisive action is necessary to avoid an undesirable outcome.

View additional details for the value we bring for the following:
• Quality Assurance (140k)
• Growing Companies (124k)
• Outsourcing Management (120k)
• Software Companies (120k)