SERVICES

IHL Consulting Group, Inc. provides FDA Consulting services to FDA Regulated Industries domestically in the United States and Internationally around the world. We serve the Pharmaceutical, Medical Device, and Biologics industries. Our FDA Consultants and former (ex-)FDA Investigators are ready to provide the following services to help ensure your regulatory success:



International Specific Services:

• Assistance with FDA Registration and Product Listings
• US Agent Services and Representation
• US Regulation Training
• International Inspection (cGMP and Pre-Approval) Training
• NDA/ANDA/BLA/CTD Submission Assistance
• PMA/510(k) Submission Assistance


Regulatory and Compliance Services (Domestic and International):

• Executive Counseling on FDA Compliance Matters
• FDA Registration and Product Listings
• Quality System Assessments
• Compliance Improvement Strategies
• Pre-Approval Readiness
• Mock ANDA/NDA/BLA Pre-Approval (PAI) and cGMP Audits
• Clinical Investigator, Sponsor and IRB Audits
• QSIT and QSR Assessments
• cGMP, GCP, and Pre-Approval Training
• NDA/ANDA/BLA (CMC) Submission Assistance
• PMA/510(k) Submission Assistance
• Vendor Audits and Qualification
• FDA 483/Warning Letter Responses
• FDA Inspection Preparation and Training
• Liaison with FDA District and Headquarter Offices
• Part 11 Assessments and Remediation Assistance


Operations and System Support (Domestic and International):

• Risk Assessment and Crisis Management
• Standard Operating Procedure Development
• Comprehensive Quality Assurance, Quality Control, Manufacturing,
   and cGMP Support
• Temporary Personnel Assistance and Substitution
• Quality Systems Design and Implementation
• Validation Support and Protocol Development
• Statistical Process Control and Quality Applications

HONEST    -    PRAGMATIC    -    RESPONSIVE