gap analysis

Kinexum provides regulatory consulting services for life science products, using experience with major agencies worldwide such as FDA, EMA, and MHRA to help clients with regulatory, nonclinical, CMC, and related development and commercialization challenges. Since 2003, Kinexum has supported over 500 companies globally with a team of more than sixty subject matter experts, most holding MDs, PhDs, MBAs, or JDs, based across North America, Europe, and Asia.

CDMO selection and managementclinical supply planning and managementCMC consultingdue diligenceFDA special designationsnonclinical study design and monitoringquality assurance and controlregulatory strategy and pathway analysisregulatory submissions (IND, NDA, BLA, IDE, 510(k), de novo, PMA)

Kopyn, LLC provides a healthcare compliance platform with tiered, scalable software solutions for small, midsize, and large healthcare organizations. The platform combines Compliance Management and Survey Readiness, featuring interactive dashboards, real-time scoring, risk assessments, automated audits, and corrective action plans. Kopyn also offers optional Fractional Compliance Officer services. It was founded by Kaimy Chappell, CHC, CCEP, who brings over 15 years of healthcare compliance and ethics experience.

compliance assessmentscontinuous monitoringcorrective action plansexecutive reportingfractional compliance officer servicesmock surveys and auditspolicy and procedure developmentregulatory liaisonrisk identification and scoringtraining and education

KoreLogic Security is a founder-operated cybersecurity firm founded in 2004, ISO 27001:2022 certified and CREST accredited, providing offensive and defensive security services to Fortune 500 enterprises and U.S. government agencies. It has delivered 1000+ cybersecurity projects, published 60+ CVEs and 105 security advisories, and has provided critical infrastructure cybersecurity consulting since 2011.

AI/LLM security testingarchitecture reviewCloud Security AssessmentcryptanalysisIT/OT and ICS/SCADA testingpassword auditing and crackingpenetration testingRed Teamingsocial engineeringsource code reviewVulnerability Research

Kruzel & Associates, LLC is an organizational consulting firm serving all levels of government agencies and private business. It provides management consulting, executive coaching, strategic planning and facilitation, workforce development and training, process and personnel gap assessment, competency development planning, individualized mentoring/coaching, and interagency/interdepartmental group facilitation. Each project begins with an introductory phase meeting key stakeholders to map solutions based on client priorities.

executive coachingfacilitationManagement consultingprocess improvementstrategic-planningTraining designworkforce development