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Regulatory Compliance | Design Group

Regulatory Compliance

Design Group is a leading supplier of validation and regulatory consulting services to the biotech, pharmaceutical, and medical device industries. Experienced engineers and scientists possessing current industry insight use proven tools and procedures to employ science and risk-based methodologies to deliver flexible and diverse solutions.

Design Group’s broad compliance solutions integrate into the project lifecycle through the execution of master planning activities, specification development, risk assessments, equipment commissioning and qualification, and cleaning and process validation. Partnerships with world-class organizations provide a simplified perspective, streamlining validation strategies that deliver robust and efficient solutions.

Experienced in regulatory enforcement actions, Design Group helps to mitigate potential findings or remediate recent observations by being a single point of accountability. This uniquely positions Design Group to provide independent quality assessments, audits, and remediate findings for client and third party contract manufacturers.

Learn more about Design Group's project experience in the Regulatory Compliance Resource Center.

  • Commissioning and Qualification

    Design Group delivers Commissioning and Qualification (C&Q) solutions and services for client facility, utility, process and packaging systems, in alignment with the latest science and risk-based standards used in industry, including ASTM E2500 and ICH Q8, Q9, and Q10.

    Trained professionals provide services including validation planning, specification development, risk assessments, root cause analysis, project management, execution of technical studies, and equipment troubleshooting while assuring safe, efficient, and compliant C&Q services.

  • Process and Cleaning Validation

    Design Group provides process validation strategies demonstrating technical understanding of process development and manufacturing methods. These strategies effectively deliver process validation programs that incorporate scientific rationale and justification to align with regulatory guidance and industry standards.

    Design Group delivers cleaning validation services to incorporate a technological understanding of clean-in-place processes, chemical compatibility studies, cross contamination risk mitigation, sampling requirements and techniques, analytical method development and validation, and technical reporting to support cleaning validation activities.

  • Quality and Regulatory Compliance

    Design Group delivers consulting services for the review of quality management systems, offering insight about the regulatory environment, recent trends, and techniques for continuous improvement concepts to ensure compliance with current regulations. Other services offered include regulatory compliance services for development of standard operating procedures, quality program documentation, annual product reviews, regulatory filings, change management system documentation, and other regulatory and compliance management documentation.

    Design Group also offers regulatory compliance services for development of standard operating procedures, annual product reviews, regulatory filings, and other regulatory management documentation.

  • Auditing

    Audit services support a wide range of regulations, standards and industries, including FDA Regulations (cGMP and GLP), ISO standards, ICH guidelines, European commission, and internal company standards for the biotech, pharmaceutical, and medical device industries using Quality Engineers and ASQ certified auditors.

  • Process Development

    Design Group professionals apply statistical and process management tools and process analytical technology (PAT) to design and implement complete solutions in process development, specifically in the areas of product development, manufacturing technical support, validation and technology transfer and use multivariate analytical (MVA) techniques and tools.  As a key input to Process Validation, these process development services support the formalization of critical process parameters and critical quality attributes.

  • Serialization

    Design Group offers an extensive packaging integration heritage as the foundation for the design, integration, and implementation of serialization solutions. Our professionals leverage knowledge and experience in program/project management, supplier relationships, automation and controls, procurement, installation management and validation to provide turn-key management of serialization solutions.