OUR SERVICES
Gabe, Inc.® is committed to provide your organization with the highest quality of services possible. Our team will demonstrate the personal attention and professional work ethic you expect in a contract provider. Our reputation reflects our mission – “…it’s OUR SERVICE that makes the difference.”
We are proficient in operating as THE OWNER REPRESENTATIVE with the following suite of services:
REGULATORY & GMP 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
Dietary Supplement Batch Re-works
Process Validation
Method Validation
Cleaning Validation
GMP Project Management
GMP Change Control
GMP Automation
GMP Controls Integration
GMP Work Order
Regulatory Specialists
Project Control Specialists
Associate Project Managers
Project Associates
Commissioning and Qualification
Analytical & CTC Support
FDA DRUG LISTING SUPPORT
FDA Establishment Registrations
FDA DRLS and eDRLS
Drug Products Re-Certifications
Labeler Code Requests
CONSTRUCTION & EHS SAFETY
Construction Management
Project Schedulers
Project Coordinators
EHS Safety Programs & Management
Field Compliance Specialists
