IHL Consulting Group
IHL Consulting Group, Inc. is a professional FDA consulting firm with over 100 years of combined regulatory compliance experience, serving the pharmaceutical, medical device, and biologics industries worldwide. They provide strategic, pragmatic, and responsive advice to help clients achieve FDA regulatory success, including compliance assessments, training, audits, and submission assistance. Their mission is to deliver high-caliber, honest, and flexible consulting services to minimize risk and support clients' regulatory needs.
Industries
Nr. of Employees
small (1-50)
IHL Consulting Group
Loganville, Georgia, United States, North America
Services
Assistance preparing and submitting regulatory filings including NDA/ANDA/BLA, CTD dossiers, PMA, and 510(k).
Pre-approval and routine inspection preparation including mock pre-approval (PAI) and cGMP audits.
Comprehensive assessments and implementation support for quality systems, QA/QC programs, and SOP development.
Delivery of training programs on US regulations, cGMP/GCP, Part 11, and international inspection practices.
Evaluation and investigative analysis of pharmaceutical samples and assessments of analytical and microbiology laboratories.
Compliance assessments and inspection support for complex medical devices, sterile device manufacturing, tissue devices, and radiological equipment.
Assistance preparing and submitting regulatory filings including NDA/ANDA/BLA, CTD dossiers, PMA, and 510(k).
Pre-approval and routine inspection preparation including mock pre-approval (PAI) and cGMP audits.
Comprehensive assessments and implementation support for quality systems, QA/QC programs, and SOP development.
Delivery of training programs on US regulations, cGMP/GCP, Part 11, and international inspection practices.
Evaluation and investigative analysis of pharmaceutical samples and assessments of analytical and microbiology laboratories.
Compliance assessments and inspection support for complex medical devices, sterile device manufacturing, tissue devices, and radiological equipment.
Expertise Areas
- Regulatory submissions and dossier preparation (drugs, biologics, devices)
- cGMP compliance and pre-approval inspections
- Quality systems design, assessment, and remediation
- Validation protocol development and execution
Key Technologies
- eCTD/CTD submission formats
- 21 CFR Part 11 / electronic records compliance
- Statistical process control (SPC)
- Quality management system frameworks (QSR/QSIT)