FDA Compliance Consulting
Expert regulatory guidance for medical device, pharmaceutical, and life sciences companies navigating complex FDA requirements
Comprehensive FDA Regulatory Compliance
AGM Network provides specialized FDA compliance consulting services to help medical device manufacturers, pharmaceutical companies,...
Why FDA Compliance Matters
FDA compliance is not optional—it's essential for market access, patient safety, and business continuity. Non-compliance...
FDA 510(k) Submissions
Complete support for 510(k) premarket notifications including strategy, documentation, substantial equivalence, and FDA interactions.
Premarket Approval (PMA)
Expert guidance through the PMA process for Class III devices, including clinical...
De Novo Classification
Support for novel devices seeking FDA classification through the De Novo pathway when no predicate device exists.
Quality System Regulation (QSR)
Implementation and maintenance of FDA 21 CFR Part 820 compliant quality systems for medical device manufacturers.
21 CFR Part 11 Compliance
Electronic records and signatures compliance for computerized systems used in FDA-regulated operations.
Medical Device Reporting (MDR)
Establish compliant post-market surveillance, adverse event monitoring, and MDR reporting systems per 21 CFR Part 803.
FDA Establishment Registration
Support for device establishment registration, device listing, and Unique Device Identification (UDI) compliance.
FDA Inspection Readiness
Prepare your organization for FDA inspections with mock audits, gap assessments, and remediation support.
Warning Letter Response
Expert assistance with FDA warning letter responses, CAPA implementation, and compliance restoration.
Clinical Trial Support
Guidance for IDE applications, clinical trial design, GCP compliance, and clinical data management.
Labeling Compliance
Ensure device labeling meets FDA requirements including IFU, package inserts, and promotional materials review.
Combination Products
Navigate complex regulatory pathways for drug-device, biologic-device, and drug-biologic combinations.
FDA Regulations We Support
- 21 CFR Part 11: Electronic Records and Electronic Signatures
- 21 CFR Part 58: Good Laboratory Practice (GLP)
- 21 CFR Part 210-211: Current Good Manufacturing Practice (cGMP) for Pharmaceuticals
- 21 CFR Part 820: Quality System Regulation (QSR) for Medical Devices
- 21 CFR Part 803: Medical Device Reporting (MDR)
- 21 CFR Part 806: Medical Device Corrections and Removals
- 21 CFR Part 812: Investigational Device Exemptions (IDE)
- 21 CFR Part 814: Premarket Approval (PMA)
- 21 CFR Part 860: Medical Device Classification Procedures
Our FDA Compliance Services
Medical Device Compliance
- Device classification and regulatory pathway determination
- 510(k), PMA, and De Novo submission preparation
- Quality System Regulation (21 CFR 820) implementation
- Design controls and risk management
- Clinical evaluation and trial support
- Post-market surveillance and vigilance
- Device master file (MAF) preparation
- Software validation and cybersecurity
Pharmaceutical & Biologics Compliance
- Current Good Manufacturing Practice (cGMP) compliance
- IND and NDA submission support
- Process validation and cleaning validation
- Stability studies and shelf-life determination
- Analytical method validation
- Batch record review and deviation management
- ANDA and biosimilar development support
Computer System Validation
- 21 CFR Part 11 compliance assessments
- CSV lifecycle documentation (URS, FRS, IQ/OQ/PQ)
- GAMP 5 compliant validation approaches
- Electronic signature and audit trail controls
- Legacy system remediation
- Vendor assessment and management
- Cloud system validation
Quality & Compliance Systems
- Document and change control systems
- CAPA and deviation management
- Complaint handling and MDR reporting
- Training and competency management
- Supplier qualification and management
- Internal audit programs
- Metrics and KPI dashboards
FDA Inspection Readiness
Our comprehensive FDA inspection readiness program includes:
- Gap Assessment: Evaluate current compliance status against FDA requirements
- Remediation Planning: Develop action plans to address identified gaps
- Documentation Review: Ensure quality system documentation is complete and current
- Mock Inspections: Simulate FDA inspections to identify potential issues
- Personnel Training: Train staff on FDA expectations and interview techniques
- Inspection Support: Onsite support during actual FDA inspections
- Response Preparation: Prepare comprehensive responses to FDA observations
- CAPA Implementation: Implement corrective actions and preventive measures
Industries We Serve
- Medical Device Manufacturers (Class I, II, III)
- In Vitro Diagnostics (IVD)
- Pharmaceutical Companies
- Biotechnology and Biologics
- Combination Products
- Software as a Medical Device (SaMD)
- Contract Manufacturing Organizations (CMOs)
- Clinical Research Organizations (CROs)
- Medical Device Distributors and Importers
- Healthcare Technology Companies
Benefits of Partnering with AGM Network
- Experienced regulatory affairs professionals
- Proven track record of successful FDA submissions
- Reduced time to market for new products
- Proactive compliance risk management
- Cost-effective compliance solutions
- Ongoing regulatory intelligence and guidance
- Preparation for inspections and audits
- Support throughout product lifecycle
- Multi-jurisdictional regulatory expertise
- Technology-enabled compliance solutions
Regulatory Strategy Development
We help you develop comprehensive regulatory strategies that align with business objectives:
- Regulatory pathway assessment and optimization
- Global harmonization strategy (FDA, EU MDR, PMDA, etc.)
- Risk-benefit analysis and mitigation planning
- Clinical and non-clinical study planning
- Regulatory submission timeline development
- Pre-submission and breakthrough device designation support
- Post-market compliance planning
- Regulatory intelligence and competitive analysis