As a Preferred Provider
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
QUICKLY AND EFFECTIVELY GET
YOUR PRODUCTS LISTED
Don’t stress on it. Pick a time on our calendar to chat about any questions
you may have about the process.
…it’s OUR SERVICE that makes the difference.