audit and inspection preparation

Assertive Transitions – Work LLC is a standards-driven advisory practice founded and led by Dr. Laura Guillion, an IACET Commissioner. It helps organizations in regulated and high-visibility environments interpret standards, design governance frameworks, and build compliance systems that support defensibility, documentation integrity, audit readiness, and accreditation outcomes.

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accreditation and credentialing supportcompliance systems designgovernance framework designquality assuranceRisk mitigationstandards interpretation

Biobanking Without Borders, LLC is a woman-owned small business providing senior biobanking consulting for complex programs. It offers integrated regulatory, governance, informatics, and operational expertise to research institutions, clinical programs, startups, non-profit research foundations, commercial entities, and large research initiatives. Services include biobank informatics and LIMS strategy, governance frameworks, informed consent and eConsent, CAP biorepository accreditation readiness, and biobank build, expansion, and relocation.

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biobank facility planning and designbiobank informatics strategybiobanking consultingbiobank relocationCAP biorepository accreditation readinessData Migrationequipment selection, qualification and validationgovernance framework developmentinformed consent draftingLIMS selection and implementationquality management systemsregulatory compliance guidancerisk assessment