Biotech & Life Sciences

Biospecimen Management Best Practices

Evaluate compliance with NCI Best Practices and ISBER guidelines for biospecimen collection, processing, storage, and distribution in research …

BMBL Biosafety Assessment

Evaluate compliance with CDC/NIH Biosafety in Microbiological and Biomedical Laboratories guidelines for safe handling of infectious agents

CA CMIA Medical Privacy Compliance

Evaluate compliance with California Confidentiality of Medical Information Act (Civil Code §56-56.37), covering patient authorization, disclosure …

CCPA/CPRA Compliance Assessment

Evaluate compliance with California Consumer Privacy Act and California Privacy Rights Act requirements for businesses handling California resident …

CLIA Compliance Assessment

Evaluate compliance with Clinical Laboratory Improvement Amendments for laboratory quality and patient safety

Assessment for Medicare Coverage Analysis and billing compliance for clinical trial services separating research costs from standard care

Assessment for research conflicts of interest management, financial disclosure requirements, and institutional COI policies per PHS and NSF …

Assessment for pharmaceutical contract manufacturing organizations covering cGMP compliance, quality agreements, and third-party oversight

Cyber Insurance Readiness Assessment

Evaluate readiness for cyber liability insurance coverage by assessing security controls, incident response, and risk management practices that …

Assessment for records management, data retention policies, and secure destruction procedures for regulated industries

EPA Hazardous Waste Management (RCRA)

Evaluate Resource Conservation and Recovery Act (RCRA) compliance for research and biotech labs generating hazardous waste, covering waste …

EPA RCRA Hazardous Waste Compliance

Evaluate Resource Conservation and Recovery Act compliance for hazardous waste generation, storage, treatment, and disposal in laboratory and …

ESG & Sustainability Reporting Readiness

Evaluate readiness for ESG (Environmental, Social, Governance) and sustainability reporting per GRI, SASB, CDP, and TCFD frameworks

EU IVDR 2017/746 - IVD Compliance Assessment

Evaluate compliance with European In Vitro Diagnostic Regulation 2017/746 for diagnostic tests, companion diagnostics, and laboratory-developed tests …

EU MDR 2017/745 Compliance Assessment

Evaluate compliance with European Medical Device Regulation 2017/745 covering device classification, quality management, clinical evaluation, …

Assessment for EAR/ITAR compliance, deemed export controls, and research security for organizations with foreign national access or international …

FDA 21 CFR Part 11 Electronic Records Compliance

Evaluate compliance with FDA 21 CFR Part 11 requirements for electronic records and electronic signatures in FDA-regulated industries

FDA 21 CFR Part 820 QSR Assessment

Evaluate compliance with FDA Quality System Regulation for medical device manufacturers - the U.S. equivalent of ISO 13485

FDA AI/ML Software as Medical Device (SaMD)

Evaluate FDA AI/ML-based Software as Medical Device compliance per 2021 guidance, covering predetermined/adaptive algorithms, algorithm change …

FDA Drug Supply Chain Security Act (DSCSA)

Evaluate DSCSA compliance for pharmaceutical track-and-trace, serialization, verification, and transaction history requirements

FDA Mobile Health App Compliance

Evaluate mobile medical app compliance with FDA guidance, 21 CFR Part 11, data security, clinical validation, and app store requirements

FedRAMP Authorization Readiness Assessment

Evaluate readiness for FedRAMP authorization to provide cloud services to federal agencies, based on NIST 800-53 security controls

GDPR Compliance Assessment

Evaluate compliance with EU General Data Protection Regulation requirements for processing personal data of EU residents

Assessment for clinical genetic testing laboratories covering CLIA high-complexity testing, FDA LDT oversight, and genetic counseling requirements

Good Clinical Practice (GCP) Compliance Assessment

Evaluate compliance with international ethical and quality standards for clinical trial design, conduct, and reporting

Good Manufacturing Practice (GMP) Assessment

Evaluate compliance with FDA Good Manufacturing Practice regulations for pharmaceutical and biotech manufacturing quality systems

Healthcare Accessibility (ADA & Section 504)

Evaluate healthcare accessibility compliance covering physical access, effective communication, program access, and auxiliary aids/services per ADA …

Healthcare Emergency Preparedness (CMS Rule)

Evaluate CMS Emergency Preparedness Rule compliance covering emergency plans, policies, communication, training, testing, and integrated healthcare …

HHS 405(d) Cybersecurity Assessment

Evaluate alignment with Health and Human Services voluntary cybersecurity practices for the healthcare industry

HIPAA Business Associate Compliance

Evaluate compliance with HIPAA Business Associate Agreement requirements for vendors and service providers handling Protected Health Information (PHI)

HITECH Act Compliance Assessment

Evaluate your compliance with the Health Information Technology for Economic and Clinical Health Act

Assessment for Institutional Animal Care and Use Committee compliance, USDA Animal Welfare Act, and PHS Policy for vertebrate animal research

ICH-GCP Clinical Trial Management

Evaluate compliance with ICH E6(R2) Good Clinical Practice guidelines for clinical trial design, conduct, monitoring, and documentation

IEC 62366 Usability Engineering Assessment

Evaluate medical device usability engineering per IEC 62366-1:2015, covering user interface design, formative and summative usability testing, and …

IRB & Human Subjects Research Compliance

Evaluate compliance with 45 CFR Part 46 (Common Rule) requirements for Institutional Review Boards and human subjects research protection

ISO 13485:2016 QMS Assessment

Evaluate compliance with ISO 13485:2016 Quality Management System requirements for medical device design, development, production, and servicing

ISO 14001 Environmental Management System

Evaluate ISO 14001:2015 environmental management system compliance, covering environmental policy, planning, implementation, monitoring, and continual …

ISO 14971 Risk Management Assessment

Evaluate medical device risk management per ISO 14971:2019, covering risk analysis, risk evaluation, risk control, and post-production risk monitoring …

ISO 27001:2022 ISMS Assessment

Evaluate alignment with ISO/IEC 27001:2022 requirements for establishing, implementing, maintaining, and continually improving an Information Security …

ISO 27017 Cloud Security Assessment

Evaluate cloud security controls per ISO/IEC 27017:2015 for cloud service providers and cloud customers, covering shared responsibility, data …

ISO 27018 Cloud Privacy Assessment

Evaluate cloud privacy controls per ISO/IEC 27018:2019 for protection of Personally Identifiable Information (PII) in public cloud environments, …

ISO 28000 Supply Chain Security Management

Evaluate ISO 28000:2022 supply chain security management system compliance, covering security risk assessment, threat mitigation, and resilience …

ISO 62304 Software Lifecycle Assessment

Evaluate medical device software development per ISO 62304:2006/AMD1:2015, covering software safety classification, development processes, risk …

ISO 9001 Quality Management System

Evaluate ISO 9001:2015 quality management system compliance, covering leadership, planning, support, operation, performance evaluation, and continual …

Lab & Facility Building Code Compliance

Evaluate building and fire code compliance for laboratory, cleanroom, and BSL facilities covering construction, life safety, egress, and specialized …

MDSAP Readiness Assessment

Evaluate readiness for Medical Device Single Audit Program certification covering FDA, Health Canada, TGA, PMDA, and ANVISA requirements in one audit

NIH Recombinant DNA Guidelines Assessment

Evaluate compliance with NIH Guidelines for research involving recombinant or synthetic nucleic acid molecules

NIST 800-53 Rev 5 Assessment

Evaluate compliance with NIST SP 800-53 Revision 5 security and privacy controls for federal information systems and organizations

NIST Cybersecurity Framework 2.0 Assessment

Evaluate cybersecurity maturity using NIST CSF 2.0 core functions: Govern, Identify, Protect, Detect, Respond, Recover - designed for all sectors …

NY SHIELD Act Compliance Assessment

Evaluate compliance with New York Stop Hacks and Improve Electronic Data Security (SHIELD) Act, covering data security safeguards, breach …

OSHA Lab Standard Compliance (29 CFR 1910.1450)

Evaluate Occupational Safety and Health Administration (OSHA) laboratory standard compliance for research and clinical labs working with hazardous …

OSHA Workplace Safety Compliance

Evaluate OSHA general industry workplace safety compliance covering hazard communication, recordkeeping, emergency action plans, and worker protection

Outbreak Investigation & Infection Control

Evaluate outbreak investigation and infection control readiness covering contact tracing, infection prevention, public health coordination, and …

Pandemic Response & Infectious Disease Preparedness

Evaluate pandemic preparedness covering surge capacity, infection control, PPE stockpiling, crisis standards of care, and workforce protection

Assessment for state pharmacy board licensure and DEA controlled substance registration for pharmacies and research facilities

Professional Liability Insurance Readiness

Evaluate readiness for professional liability insurance (E&O, D&O, malpractice) by assessing risk management practices, documentation, and governance

Public Health Reporting & Surveillance

Evaluate public health reporting compliance covering disease surveillance, immunization registries, syndromic surveillance, and vital statistics …

Remote Patient Monitoring (RPM) Compliance

Evaluate remote patient monitoring program compliance covering CMS reimbursement, device accuracy, data transmission security, and clinical workflows

Research Data Management & FAIR Principles

Evaluate research data management practices including FAIR principles (Findable, Accessible, Interoperable, Reusable), data integrity, and regulatory …

SOC 2 Type II Readiness Assessment

Evaluate readiness for SOC 2 Type II audit based on AICPA Trust Services Criteria for security, availability, processing integrity, confidentiality, …

Telehealth & Telemedicine Compliance

Evaluate telehealth program compliance covering state licensure, prescribing rules, HIPAA security, informed consent, and reimbursement requirements

Texas Medical Privacy Compliance

Evaluate compliance with Texas Health & Safety Code Chapter 181 (Medical Records Privacy), covering protected health information, patient consent, …

Assessment for third-party vendor security, risk assessments, business associate agreements, and vendor lifecycle management