Barile and Associates
Barile & Associates, Inc is a global consulting firm specializing in regulatory affairs, quality assurance, compliance, operations, manufacturing, validation, information technology, and human resources for the medical device, pharmaceutical, human tissue, and biotechnology industries. With offices across North America, the Middle East, Asia, and Europe, the company provides expert support to help clients navigate complex regulatory environments, develop and validate processes, and improve product quality and compliance.
Industries
Nr. of Employees
small (1-50)
Barile and Associates
Clinton, New Jersey, United States, North America
Products
Pre-recorded regulatory and quality training (webinar CDs and DVD seminars)
Recorded training modules covering topics such as CAPA systems, QSR requirements for executives, design control, process validation, software validation and regulatory compliance. Materials include slide presentations with narration and self-examinations with answer keys for training records.
Pre-recorded regulatory and quality training (webinar CDs and DVD seminars)
Recorded training modules covering topics such as CAPA systems, QSR requirements for executives, design control, process validation, software validation and regulatory compliance. Materials include slide presentations with narration and self-examinations with answer keys for training records.
Services
Support for regulatory strategy, submission preparation, inspection readiness, and remediation of enforcement actions.
Design, deployment and remediation of quality management systems, CAPA program implementation and root cause investigations.
Process design, scale-up, validation and equipment qualification for new and existing manufacturing lines.
Validation of computerized systems, software life-cycle support, and compliance auditing against electronic records and software validation guidance.
Clinical study design support, monitoring and auditing services for clinical investigations and trials.
Regulatory and quality-focused training delivered as recorded webinars/DVDs or as live on-site or web-based courses; public lectures at industry events.
Support for regulatory strategy, submission preparation, inspection readiness, and remediation of enforcement actions.
Design, deployment and remediation of quality management systems, CAPA program implementation and root cause investigations.
Process design, scale-up, validation and equipment qualification for new and existing manufacturing lines.
Validation of computerized systems, software life-cycle support, and compliance auditing against electronic records and software validation guidance.
Clinical study design support, monitoring and auditing services for clinical investigations and trials.
Regulatory and quality-focused training delivered as recorded webinars/DVDs or as live on-site or web-based courses; public lectures at industry events.
Expertise Areas
- Regulatory compliance and submissions
- Quality systems development and remediation
- Process development and validation
- Clinical trial design, monitoring and auditing
Key Technologies
- Regulatory submission pathways (510k, PMA, IDE, IND, NDA, BLA)
- Design controls and verification/validation
- Process validation and equipment qualification
- Cleanroom commissioning
News & Updates
Medical Device “Silent Recalls” - CDRH is on the Lookout- Are You Prepared?
A webinar discussing FDA's approach to silent recalls, how to determine if a device issue is a reportable event, and how to prepare for FDA inspections.
US FDA Quality System Regulation (QSR) – What Executives & Senior Managers Must Know
A webinar providing an overview of the FDA QSR requirements, responsibilities of senior management, and how to ensure compliance.
How to Anticipate and Avoid Regulatory and Compliance Hurdles in Medical Device Development
A webinar summarizing regulatory hurdles in product development and strategies to avoid them.
Medical Device “Silent Recalls” - CDRH is on the Lookout- Are You Prepared?
A webinar discussing FDA's approach to silent recalls, how to determine if a device issue is a reportable event, and how to prepare for FDA inspections.
US FDA Quality System Regulation (QSR) – What Executives & Senior Managers Must Know
A webinar providing an overview of the FDA QSR requirements, responsibilities of senior management, and how to ensure compliance.
How to Anticipate and Avoid Regulatory and Compliance Hurdles in Medical Device Development
A webinar summarizing regulatory hurdles in product development and strategies to avoid them.