The Generic Drug User Fee Amendments (GDUFA) program plays a critical role in the review, inspection, and approval of generic drugs and APIs in the United States. Our GDUFA Assessment services help API manufacturers, DMF holders, and pharmaceutical companies understand, assess, and comply with US FDA GDUFA requirements, ensuring uninterrupted regulatory review and market access.
We provide accurate assessment support, compliance verification, and readiness guidance to help organizations avoid delays, deficiencies, or regulatory actions related to GDUFA obligations.
Comprehensive GDUFA Assessment & Compliance Support
Our services cover the full scope of GDUFA-related requirements—from facility identification and fee assessment to inspection readiness and lifecycle compliance.
Scope of GDUFA Assessment Services
- GDUFA Assessment Services
- Identification of GDUFA facility classification (API, FDF, CMO)
- Assessment of DMF holder obligations
- Verification of facility and site data accuracy
- Alignment with FDA GDUFA definitions and timelines
- GDUFA Fee Assessment & Compliance
- Evaluation of applicable GDUFA fees
- Support for self-identification requirements
- Compliance checks for DMF and facility fee obligations
- Risk assessment for non-compliance or late submissions
- Self-Identification & Registration Support
- GDUFA self-identification assessment
- Data consistency checks across FDA systems
- Coordination with US Agent and site registration data
- Support for updates and corrections
- Inspection Readiness under GDUFA
- GDUFA-linked FDA inspection preparedness
- GMP readiness assessment for API and FDF facilities
- Review of compliance history and inspection risks
- Support for post-inspection actions
- Ongoing GDUFA Lifecycle Support
- Annual GDUFA compliance review
- Change management and impact assessment
- Support during FDA queries or enforcement actions
- Integration with DMF and regulatory submission activities
Regulatory Framework Covered
Our GDUFA assessment services are aligned with:
- US FDA GDUFA Regulations & Guidance
- 21 CFR Parts 210 & 211
- US FDA DMF Requirements
- FDA Facility Self-Identification Rules
- ICH Q7 & cGMP Expectations
This ensures full compliance with current FDA requirements.
Risk-Based & Accuracy-Driven Approach
We follow a risk-based and data-accuracy-focused approach to GDUFA assessment. Correct classification, timely self-identification, and fee compliance are essential to avoid FDA review delays, DMF holds, or inspection prioritization issues.
Key Deliverables
- GDUFA applicability and compliance assessment report
- Facility and DMF obligation verification
- Risk assessment and compliance roadmap
- Self-identification and fee readiness confirmation
- Inspection-ready GDUFA compliance records
Why Choose Our GDUFA Assessment Services?
- US FDA Regulatory Expertise
Deep understanding of GDUFA requirements and enforcement trends. - Prevention of Costly Delays
Early identification of compliance gaps and risks. - Integrated Regulatory Support
Seamless alignment with US DMF, eCTD, and US Agent services. - Accurate & Timely Compliance
Reduces risk of DMF review holds and application delays. - Confidential & Secure Handling
Protection of sensitive regulatory and facility data.
Who We Support
- API Manufacturers
- US DMF Holders
- Finished Dosage Form (FDF) Manufacturers
- Contract Manufacturing Organizations (CMOs)
- Export-Oriented Pharmaceutical Companies
- New Entrants to the US Generic Market
Stay GDUFA-Compliant. Stay Market-Ready.
With the FDA’s increased focus on risk-based inspections and fee compliance under GDUFA, proactive GDUFA Assessment is essential for regulatory success. Our structured and regulator-aligned approach ensures your organization remains compliant, inspection-ready, and positioned for timely approvals.
