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Quality and compliance support

Expertise for products of all types, and teams of all sizes

Quality Management Systems

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  • Development and implementation

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  • Documentation management

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  • Workflow/gap analysis

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  • Selection and Implementation of electronic QMS

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  • Key experience with GxP facility  setup and process control

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  • Support for achieving ISO certifications including ISO-13485, -14971. -10993, -62304, -9001

Audit & Inspection Support

  • Internal audit process development informed by extensive knowledge of ISO-13485, ISO-9001, and MDSAP standards

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  • Audit readiness preparation backed by years of experience conducting GxP audits

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  • Extensive and recent experience hosting planned regulatory agency inspections

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  • Recommendation of process improvements and leading internal compliance audits

Regulatory Compliance
 

  • ​​​Identification of relevant industry regulations and standards 

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  • Vendor/Supplier Qualification Program design and implementation

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  • Change management

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  • CAPA and remediation of inspection findings

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  • Risk management

Cross-functional interim leadership

  • Serve as an institutional liaison on regulatory and quality matters to avoid interruption of progress during hiring and restructuring

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  • Applying executive leadership experience in Chief Operations Officer, Vice President RA/QA, Compliance Officer and Quality Assurance Officer roles to serving interdisciplinary teams

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  • Strategic planning for growing businesses, mentorship and coaching for growing team leaders

Connect to discuss how to build or improve your quality infrastructure

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Training and education 

Partnering with companies and universities to provide purpose-built training and professional development resources in regulatory affairs and quality assurance (QA) and business development including

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  • Online courses

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  • Webinars

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  • Interactive sessions

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  • Course development consultation

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  • Speaker engagements

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Key topics

  • GxP: laboratory setup, SOP standardization, and facilities management that ensures the quality and safety of products along with GCP-specific training covering human subject protection across different types of clinical research

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  • Regulatory Submissions: Understanding the processes and requirements for submitting regulatory applications to agencies like the FDA. These sessions are tailored to medical devices, drugs, and/or biologics as all differ in their requirements and process

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  • Quality Systems: Implementing and maintaining quality systems that ensure compliance with regulations and standards applicable to specific medical product lines

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  • Auditing: Conducting internal quality and compliance audits to identify areas for improvement as well as regulatory authorities inspectional readiness

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  • Technical Writing: Developing effective technical documentation and reports, including Common Technical Document (CTD) and other key standard forms

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  • Post-Approval Changes: Understanding the regulatory procedures for making changes to approved products

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  • Global Regulations: Navigating the complexities of international regulatory requirements

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