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ProQuality Network: Upholding Compliance Across the Product Lifecycle

Updated: Feb 9

The importance of product quality eclipses any flyers, billboards, or digital presence when it comes to influencing customer acceptance. This significance is even more pronounced in the pharmaceutical industry, where cGMP compliance is mandatory from product design to the moment it graces pharmacy shelves.

What pharmaceutical companies require is an experienced partner specializing in comprehensive quality assurance, one that guarantees product integrity from inception to end-user delivery.

ProQuality Network is a steadfast ally of pharmaceutical companies, ensuring stringent compliance requirements are met and upheld throughout the product lifecycle. Its team of professionals, possessing in-depth expertise spanning the entire range of cGMP applications, are the first-choice third-party consultants when dealing with FDA compliance. ProQuality also conducts comprehensive assessments and on-site and virtual audits. The company provides support for compliance assessments and management strategies, remediation plans, site inspections readiness and enhancement plans, and oversight services.

The women- and minority-owned and HUBZone-certified company has earned the position of a registered contractor of the federal government and is affiliated with key industry organizations like the Parenteral Drug Association (PDA). Serving as a third-party consulting group, the company represents its clients in their interactions with regulatory bodies.

"We serve as trusted representatives, guiding clients through FDA and global regulatory compliance to ensure adherence to expected product standards," says Elizabeth Plaza, president of ProQuality Network.

With a legacy of over 30 years as a scientist and consultant and a track record of successfully completing 20,000+ projects, Plaza understands that customers place their faith in individuals more than in a corporate entity. Her dedication to maintaining trust enabled her to work with clients across Europe, USA, South and Latin America, taking care of compliance projects, technology transfers, and scientific services.

ProQuality's operational methodology is highly adaptable to the specific needs of each client and project. If clients require comprehensive project management to guarantee the success of projects objectives, its team implements project controls, governance, and communication plans to meet or better to exceed the goals.

When managing regulatory challenges, a structured protocol, often referred to as an 'oversight protocol' or a 'remediation protocol' which is scientifically sound on its approach, and which includes key performance indicators (KPl's) serves as a documented roadmap for expected outcomes. The scientific approach includes mentoring customer's employees and enhancing the knowledge profile to guarantee sustainable results.

The company's distinct approach, encapsulated in the acronym C-P-Q-K-T, forms the foundation of the services it extends-compliance, project, quality risk, knowledge management, and talent development.

Its compliance services can be either proactive in enhancing quality beforehand, or reactive, involving remediation in response to enforcement actions or gaps initiatives.

In its project management, the company employs advanced methodologies and insights to guarantee that projects are appropriately directed in terms of execution, resource allocation, reporting, and budgetary control.

We serve as trusted representatives, guiding clients through FDA and global regulatory compliance to ensure adherence to expected product standards

One of its key areas of expertise is ensuring that quality systems are consistently followed, guaranteeing controlled processes and a validated state across the product lifecycle. It addresses the growing demand for quality risk management, as mandated by the FDA, through periodic review of risks to enable continuous improvement and achieve an Integrated Quality Management system.

The complex regulatory compliance landscape demands experienced talent. ProQuality has earned recognition for its wealth of talent and experience, having a network of over 100 consultants actively engaged and a pool of over 1000 available on demand. It offers seasoned consultants and contractors who become an integral part of clients' teams, extending their resources and providing mentoring, coaching, and technical skills enhancement on-site to improve compliance profiles.

Apart from these services, ProQuality is also at the forefront of the digital transformation of the pharmaceutical industry. It partners with clients to provide digital platforms, aiding them in going paperless and managing product lifecycles in a digital environment. It recognizes the industry's move toward data analytics, data science, data management, and artificial intelligence and incorporates these cutting-edge technologies to help clients adapt to the evolving digital landscape.

ProQuality Network serves as a reliable ally for pharmaceutical companies in their pursuit of uncompromising quality metrics. By bridging resource gaps and providing expertise, it enables pharmaceutical businesses to prioritize their core activities while upholding the highest standards of compliance and integrity throughout the product lifecycle.

This article has been published originally by © Pharma Tech Outlook.

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