COMPLIANCE

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At Gabe, Inc.®, we specialize in providing comprehensive and reliable pharmaceutical services to support the entire lifecycle of drug development and manufacturing. With decades of industry expertise, we offer a full spectrum of solutions to help companies remain compliant with the ever-evolving FDA regulatory standards. 

Our team of dedicated professionals is committed to upholding the highest standards of quality, compliance, and efficiency. By leveraging cutting-edge technologies, industry best practices, and a customer-centric approach, we empower pharmaceutical companies to bring safe and effective products to market faster. We are proud to be a trusted partner in advancing global healthcare through our exceptional services and unwavering commitment to excellence.

 REGULATORY & QUALITY SUPPORT 

• Drug and Dietary Supplement Labeling Regulatory Review
• Audits – GMP, Compliance, ISO 9001, Quality Systems, Process, Product, Food Safety, ISO 13485
• Regulatory Filings/Submissions – IND, NDA, ANDA, 510K
• Manufacturing Process Development/Improvement
• Formulation Development/Improvement
• Process Validation
• Method Validation
• Cleaning Validation
• Regulatory Specialists
• GXP Auditing & Gap Assessments
• GXP Regulatory Inspection Support & Training
• QMS, EDMS, ERP Implementation, Support & Training
• Validation and Qualification (IQ, OQ, PQ, UAT, URS, FRS and ROI)
• Medical Device Quality Systems (MDSAP, MDR, or FDA Pre-assessment)
• Software SOP Development
• Supplier/Contract Service Provider Audits (CMO, CRO, CTL, Software, etc.)
• Data Integrity
• Quality Assurance (Batch Record Review, SOP development, etc.)
• Management and Design Controls
• Risk Management
• Manufacturing Compliance Oversight
• Manufacturing Engineering and Support
• Laboratory Controls – Analytical/Quality Control (QC) and CTC Support
• GDP, GLP, GCP and GMP Training

  FDA DRUG & COSMETIC REGISTRATION & LISTING SUPPORT 

• FDA Establishment Registrations
• FDA DRLS and eDRLS
• Drug & Cosmetic Products Re-Certifications
• Labeler Code Requests