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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.

 

Industry
Focus

Life Sciences

View Project profiles
  • Commissioning & 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 the industry including ASTM E2500 and ICH Q8, Q9, and Q10.

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

  • Computer System Validation

    Design Group's multi-disciplined services allow for a partnership between the Regulatory Compliance, Control System Integration, and Enterprise Technology Consulting Practices to build a robust computer and software validation program for systems at all levels of the ISA 95 pyramid. Support can range from program development to development of clear and robust specifications, to the integration of key elements and ERES compliance, to the application of GAMP 5-based risk management tools, and the generation and execution of custom validation protocols.

  • Process & 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.

    We deliver 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 & 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, root cause analysis, change management system documentation, and other regulatory and compliance management documentation.

    We also offer regulatory compliance services for the 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. This is specifically in the areas of product development, manufacturing technical support, validation and technology transfer and use multivariate analytical (MVA) techniques and tools. These process development services support the formalization of critical process parameters and critical quality attributes as a key input to Process Validation.