regulatory strategy development

Epsilon Associates is an environmental consulting firm founded in 1997 whose scientists, planners, and engineers help clients navigate complex environmental regulations and secure approvals for real estate, energy, and infrastructure projects. The firm has supported more than 3,000 projects across the Northeast and offers services including permitting, acoustics and noise, air quality, ecological sciences, coastal and marine, GIS, and historic preservation.

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acoustics and noise analysisair quality analysiscoastal and marine consultingecological sciencesEnvironmental Compliance and PermittingGIShistoric preservation planning

Evergreen Strategic Consulting, LLC is the consulting practice of Dr. Carrie M. Huffman, MA, MPH, LPD, RAC, providing regulatory, clinical, and policy consulting for the medical device industry. With over 25 years of experience in epidemiology, medical devices, regulatory and clinical affairs, and patient-focused policy, she offers expertise in regulatory affairs, clinical evidence, patient preference and engagement, and advocacy for patient-centric healthcare policy.

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clinical affairs SOP developmentEU MDR strategy, readiness and submissionIDE study design and executioninspection and warning letter responsemedical device Early Feasibility Studies (EFS)observational and interventional study designpatient interviews and focus groupspatient preference studiesPMS, PMCF, CEP, CER, PSUR and SSCP developmentpolicy position development and writingpost-market data collection, analysis, and trendingquality system development, review, and compliancerecall review, documentation, and implementationregulatory authority engagementsurvey studies