CONSULTING PROGRAMS

DGD Solutions is now partnered with a premier injection molding company located in the Knoxville, Tennessee area.  With machines from 20 tons to 300 tons, we have the capacity and expertise you need.  Reach out today and allow us to solve your plastics needs.

DGD Solutions provides a simple, value-added, systematic, and sustainable approach to regulatory compliance. We ensure adherence to key industry standards such as ISO 13485, FDA CFR 21 Part 11, Part 210, Part 211, and Part 820. Our services include conducting thorough CAPA investigations, managing root cause analyses, and implementing effective remediation efforts to address regulatory findings, including 483s and Warning Letters.

We guide organizations through the complexities of regulatory frameworks with a focus on practical, long-term solutions, from Quality Management System (QMS) implementation and audits to ensuring compliance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP). Whether your organization is navigating new product development, market release, or ongoing compliance requirements, we deliver the strategic insight needed to consistently meet and exceed regulatory expectations.

We specialize in the development, implementation, and optimization of QMS that comply with industry standards such as ISO 13485, ISO 9001, and FDA CFR 21 Part 820. Our expertise includes performing comprehensive GAP assessments, creating and refining Standard Operating Procedures (SOPs), Work Instructions, and related documentation, and conducting internal and external audits.

We focus on practical, long-term solutions that drive continuous improvement and ensure that your QMS aligns with both regulatory requirements and business objectives. Whether you are establishing a new QMS or enhancing an existing one, DGD Solutions provides the strategic insight and operational support needed to build a robust system that consistently delivers quality and compliance.

We also specialize in managing complex, cross-functional projects within regulated environments such as medical devices and pharmaceuticals. Our expertise includes leading full-cycle ERP implementations, overseeing product development from concept to market launch, and managing large-scale inventory and product transfers.

We apply proven methodologies, including Lean Manufacturing, Six Sigma, and Value Stream Mapping, to ensure projects are completed on time, within scope, and on budget.

Whether your project involves process improvements, system integration, or operational optimization, DGD Solutions provides the strategic oversight and practical execution needed to achieve successful outcomes while maintaining compliance with industry standards.

We specialize in identifying inefficiencies, streamlining operations, and implementing best practices across your organization. Our expertise includes deploying Lean Manufacturing principles, Six Sigma techniques, and Value Stream Mapping to drive continuous improvement and enhance operational performance.

We focus on reducing waste, optimizing workflows, and increasing productivity while ensuring compliance with industry standards such as ISO 13485 and FDA CFR 21 Part 820. Whether you are looking to refine your production processes, improve quality control, or reduce lead times, DGD Solutions provides the strategic guidance and hands-on support needed to achieve measurable and lasting improvements.

DGD Solutions provides a simple, value-added, systematic, and sustainable approach to Enterprise Resource Planning (ERP) systems. We specialize in the selection, implementation, and optimization of ERP systems tailored to your organization's unique needs. Our expertise spans full-cycle ERP implementations, system customization, and seamless integration with platforms like SAP, Oracle, and NetSuite.

We guide you through the ERP selection process, ensuring the chosen system aligns with your business objectives and regulatory requirements. Our focus is on enhancing operational efficiency, improving data accuracy, and supporting strategic decision-making.

Whether you're implementing a new ERP system or upgrading an existing one, DGD Solutions offers the strategic insight and practical support needed to drive success and ensure long-term sustainability.

We specialize in optimizing procurement workflows, enhancing supplier relationships, and ensuring compliance with industry standards such as ISO 13485 and FDA CFR 21. Our services include developing and refining purchasing strategies, conducting thorough supplier audits, and managing supplier performance to meet quality and regulatory requirements.

We focus on creating efficient Procure-to-Pay processes, negotiating favorable contracts, and implementing strategic sourcing initiatives that drive cost savings and improve supply chain reliability.

Whether you're looking to streamline your purchasing operations or enhance supplier quality management, DGD Solutions provides the expertise and practical tools needed to achieve your procurement goals and build a resilient supply chain.

At DGD Solutions, our expertise extends beyond traditional offerings to include a range of specialized services that add value across your organization. We excel in technical writing, creating comprehensive SOPs, Work Instructions, and training materials that ensure clarity and compliance. Our experience with process validations, including sterile packaging, contamination controls, and equipment qualification, ensures that your operations meet the highest standards of quality.

We also offer in-depth knowledge of environmental controls, including ISO Class 7 and Class 8 cleanrooms, and can guide your organization through complex regulatory landscapes such as combination products and biologics. Our hands-on approach to data migration, system integrations, and due diligence activities ensures seamless transitions during mergers and acquisitions.

Whether you need support in niche areas or comprehensive project management, DGD Solutions provides the expertise needed to address your unique challenges with precision and efficiency.