Two Partners. Two Practical Principles. One Powerful Approach.
The Practical Solutions Group, LLC
11 Seminary Avenue
Hopewell, NJ 08525
P: 609.683.0756

Regulatory Compliance Simplified.

The Practical Solutions Group, LLC is a consultancy to pharma, biotech, medical device and supporting companies
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Our Value Proposition

Using principles of operational efficiency as our starting point, 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.

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Capability Statement

We focus on GXP/ISO compliance from the operational and risk-based perspectives, encouraged by the FDA itself, allowing us to provide deliverables that help company management to make sound business decisions regarding the status of company operations. Our view is that every regulatory issue is symptomatic of a much larger operational problem, and we help companies to avoid and/or remedy both.

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Core Areas of Expertise

Quality Infrastructure and Business Processes
Computer Systems Validation/21 CFR Part II
Audits and Assessments
Selecting and Managing Outsource Partners