Compliance Team
Regulatory compliance consulting firm focused on regulated healthcare and life‑science industries. Services described in the sourced content include compliance program design and implementation, quality management system (QMS) support, cleaning validation and validation protocol development, data integrity and computerized system compliance (including 21 CFR Part 11 topics), FDA inspection readiness and mock audits, and advisory on emergent topics such as AI in medical devices and 3D medical printing. Service delivery is presented as consulting, training, auditing, and project support for product launches.
Industries
Nr. of Employees
small (1-50)
Compliance Team
Buffalo, New York, United States, North America
Products
Pharmaceutical Compliance
Support for manufacturing, computer system, and laboratory validation requirements, including GMP, QA, and QMS audits, data-integrity risk assessments, and assistance with drug applications.
Medical Device Compliance
Assistance with regulatory management, quality management, risk management, and submissions for medical devices, including FDA, EU, and Health Canada standards.
Clinical Trial Compliance
Support for clinical trial compliance, including GCP audits, FDA inspection readiness, and clinical operations SOP development.
Audit Compliance Program
Monitoring of quality systems through regular audits to identify gaps and initiate corrective actions, ensuring compliance with FDA and ISO standards.
Clinical Lab Compliance
Development of compliance strategies for laboratory-developed tests, including training, gap analysis, and premarket submission support.
Pharmaceutical Compliance
Support for manufacturing, computer system, and laboratory validation requirements, including GMP, QA, and QMS audits, data-integrity risk assessments, and assistance with drug applications.
Medical Device Compliance
Assistance with regulatory management, quality management, risk management, and submissions for medical devices, including FDA, EU, and Health Canada standards.
Clinical Trial Compliance
Support for clinical trial compliance, including GCP audits, FDA inspection readiness, and clinical operations SOP development.
Audit Compliance Program
Monitoring of quality systems through regular audits to identify gaps and initiate corrective actions, ensuring compliance with FDA and ISO standards.
Clinical Lab Compliance
Development of compliance strategies for laboratory-developed tests, including training, gap analysis, and premarket submission support.
Services
Cleaning validation services
Consulting and execution support for cleaning validation programs, including protocol development and compliance assessment.
Compliance program development
Design and implementation of enterprise compliance programs, including policies and procedures.
QMS implementation and data integrity integration
Support for establishing or updating quality management systems with integrated data integrity controls.
FDA inspection readiness and mock audits
Preparation for regulatory inspections through readiness assessments, mock audits, and documentation reviews.
Computerized system validation and Part 11 advisory
Planning and execution support for computerized system validation and electronic records/electronic signatures compliance.
Medical device software and AI advisory
Regulatory and risk advisory for AI and software used in medical devices, including development and premarket considerations.
Cleaning validation services
Consulting and execution support for cleaning validation programs, including protocol development and compliance assessment.
Compliance program development
Design and implementation of enterprise compliance programs, including policies and procedures.
QMS implementation and data integrity integration
Support for establishing or updating quality management systems with integrated data integrity controls.
FDA inspection readiness and mock audits
Preparation for regulatory inspections through readiness assessments, mock audits, and documentation reviews.
Computerized system validation and Part 11 advisory
Planning and execution support for computerized system validation and electronic records/electronic signatures compliance.
Medical device software and AI advisory
Regulatory and risk advisory for AI and software used in medical devices, including development and premarket considerations.
Expertise Areas
- Regulatory compliance
- Validation and cleaning validation
- Quality management systems (QMS)
- Inspection readiness and audits
Key Technologies
- 3D medical printing (additive manufacturing)
- AI/ML for medical devices
- Computerized system validation
- Quality management systems (QMS)