FDA Audit Services California 

Looking for FDA Audit Services in California? Core Compliance provides FDA Audit consulting to ensure regulatory compliance. 

Flexible Regulatory Audit Consulting options:

1. Hourly Ad Hoc
2. Short-term project 
3. Long-term contractual agreement (Remote or Onsite)

Do you have a pending FDA Audit to prepare for and would like an experienced FDA consultant to evaluate current state, prepare and train your organization? Core Compliance has Regulatory FDA consultants that can step in and guide your company to FDA compliance at all stages in evaluating product quality, personnel performance, and production efficiency.

FDA Audit services include,

• CAPA management
• Pre Approval Inspections (PAI)
• Multi-Country Registration & Approval
• 510k CE Mark compliance
• GxP Audits
• FDA Mock Inspections
• ISO 13485:2016 ISO 9001:2015
• Internal Audits
• Validation Computer Systems Audit
• MDD/IVDD/AIMDD Compliance Audits
• GMP, GLP and GCP environments and state-of readiness assessments

Receive an initial health check of your products, systems, and manage systems to meet FDA requirements with a clear road map to maintain FDA regulatory compliance. We have expertise in the following industries, Medical Devices, Pharmaceutical and In-Vitro Diagnostics.

Audit Registration Approval

Core Compliance provides FDA Audit services in California for registrations & submissions to ensure compliance. We assist all types of companies requiring regulatory compliance for products & systems to Multi-Country Registration and Approvals in assessing regulatory compliance & regulations. No need to hire a full-time employee to manage all of the regulatory requirements, our FDA Regulatory consultants give your organization the flexibility for Ad-Hoc hourly basis or retain them for a set amount of hours monthly. Learn more, FDA requirements for medical device products compliance.

Our FDA Regulatory consultants provide the following: 

• Multi- Country Registration & Approvals US 510K EU CE Mark Health Canada MDL
• Independent review Product Submissions/Compliance
• Technical File review EU 
• CE Mark Compliance Assessments
• New Product development process
• FDA Regulatory compliance road map

FDA Mock Inspections

Looking to get a FDA mock inspections for GMP, GLP and GCP environments and state-of readiness assessments? Core Compliance provides (Quality System Regulation) mock audits to help prepare for an FDA inspection to ensure compliance with our experienced consulting experts. Get the peace of mind knowing you will be prepared for an upcoming FDA audit. See FDA Inspection Guide- https://www.fda.gov/iceci/inspections/inspectionguides/ 

Our FDA Consultants set a schedule for the FDA mock inspection with clear agenda with your management team. Initially gathering current processes, procedures, product info for a gap analysis. Core Compliance FDA consultants walk through & review your production facilities, utilities, validation, testing and other manufacturing documentation, providing an initial FDA compliance health check, in creating a road map and training.  Based upon management review, our consultants schedule another walk-through to implement recommendations and compliance for FDA audit preparation. 

• FDA Audit preparation
• FDA Mock Inspection
• Regulatory FDA Document review and preparation
• Pre-inspection Audits
• Evaluate process controls, records and document control systems for compliance
• Compliance of contract services providers 
• Supplier Audit review

ISO Compliance Services

 Our FDA Regulatory consultants in California provide comprehensive review of your current quality, risk and medical device management system to ensure your organization is current to ISO 9001:2015 & ISO 13485:2016 ISO 14971:2012

The ISO certification process is a key aspect on the road map for FDA compliance. Core Compliance consultants specialize in reviewing or developing a Quality Management System that represents your Medical Device organization internal business processes and procedures and incorporating necessary requirements for compliance with ISO 9001 ISO 13485 ISO 14971 standards.

Regulatory Audit Services

We have FDA experienced auditors for your quality system yields benefits beyond meeting FDA requirements. It assures that your quality system is providing the information you need to manage product quality, personnel performance, and production efficiency – information essential to business success.

FDA Audits performed include:

• CAPA handling and closure
• CE Mark Compliance Assessments
• Complaint handling
• Compliance audits, assessments, and gap analyses
• Compliance Engineering Support
• Computer systems audits and Part 11 assessments and remediation
• Comprehensive remediation strategies
• Due Diligence and Compliance Audits, Assessments and Remediation Strategies
• FDA mock inspections for GMP, GLP and GCP environments and state-of readiness assessments
• Gxp Audits
• ISO 13485/ISO 9001
• Medical device audits for 21 CFR Parts 820 (QSR and QSIT audits)
• MDD/IVDD/AIMDD Compliance Audits
• Mock FDA GxP inspections
• Mock Pre-Approval Inspection (PAI)
• Multi-Country Registration and Approvals
• Preparation of responses to FDA 483, citations, and warning letters
• Quality System/GMP Audits using FDA QSIT Techniques
• Routine internal audits
• Software Quality Assurance and SW V&V Auditing
• Strategic GxP Compliance Consulting: GCP, GLP, GCP
• Supplier QA audits
• Supply-chain audits
• Validation audits Start the process

ISO Standards

Core Compliance has expertise in the following ISO standards:

ISO 9001:2015 –Quality Management Systems
ISO 13485:2016 FDA Compliance 510K Submission CE Marking –Medical Devices Quality Management Systems
ISO 17025–Testing & Collaboration Laboratories Management
AS 9100–Aerospace Industry Quality Management Systems
ISO/IEC 20000:2011–Information Technology Service Management
ISO/IEC 27001:2011–Information Technology Security Management
R2:2013 RIOS Electronics Recycling NAID -Information Destruction e-Stewards –Responsible Recycling and Reuse of Electronics
ISO 14001- Environmental Management Systems
OHSAS 18001 ISO 45001 –Occupational Health & Safety Management
ISO/TS 16949-Automotive Industry Quality Management Systems