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USFDA Pharmaceutical, Medical Device
and Biologics Regulatory Consulting
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

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