SERVICES

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

 

LEARN MORE