Phil Triolo and Associates
Phil Triolo and Associates is a regulatory consulting firm specializing in medical device, drug, and in vitro diagnostic (IVD) product development and regulatory approval. They provide expert assistance to accelerate medical product development, ensure compliance with international regulations, and facilitate quick regulatory approvals. Their services include regulatory assessment, quality system development, clinical evaluation, pre-market submissions, and specialized expertise in drugs, combination products, electronic submissions, crisis management, and biocompatibility. The company aims to deliver timely, cost-effective regulatory documentation and support to clients worldwide.
Industries
Nr. of Employees
small (1-50)
Phil Triolo and Associates
Services
Regulatory assessments and strategies for early-stage medical product development and sequential quality system development and implementation.
International regulatory strategy development, pre-submission meeting support, design control implementation, clinical investigation planning, pre-market submission preparation, supplier evaluations, and electronic submission preparation.
Quality system implementation and auditing to ISO 13485 and FDA QSR, process validation, complaint handling procedures, crisis management including regulatory inspection responses and recalls, and manufacturer registration/device listing support.
Agent and correspondent services for regulatory authorities, issuance of certificates to foreign governments, and remediation support for import/export detentions.
Audit of quality systems, design documentation, and regulatory records to evaluate completeness and strength of regulatory and quality assets.
Services including DMF preparation and maintenance, pharmaceutical packaging DMFs, electronic submission preparation (eCTD/DMF/eCopy), biocompatibility and biological safety consulting, and crisis management for regulatory inspection responses and recalls.
Regulatory assessments and strategies for early-stage medical product development and sequential quality system development and implementation.
International regulatory strategy development, pre-submission meeting support, design control implementation, clinical investigation planning, pre-market submission preparation, supplier evaluations, and electronic submission preparation.
Quality system implementation and auditing to ISO 13485 and FDA QSR, process validation, complaint handling procedures, crisis management including regulatory inspection responses and recalls, and manufacturer registration/device listing support.
Agent and correspondent services for regulatory authorities, issuance of certificates to foreign governments, and remediation support for import/export detentions.
Audit of quality systems, design documentation, and regulatory records to evaluate completeness and strength of regulatory and quality assets.
Services including DMF preparation and maintenance, pharmaceutical packaging DMFs, electronic submission preparation (eCTD/DMF/eCopy), biocompatibility and biological safety consulting, and crisis management for regulatory inspection responses and recalls.
Expertise Areas
- Regulatory strategy and submission preparation
- Quality management systems and ISO 13485/FDA QSR compliance
- Clinical investigation planning and GCP compliance
- Electronic regulatory submissions and DMF management
Key Technologies
- Electronic Common Technical Document (eCTD) submissions
- Electronic submission gateways and eCopy formats
- ISO 13485 and FDA Quality System Regulation (QSR) compliance
- Design verification and validation protocols