Pharmaceutical
Vi-Leon connects pharmaceutical companies with specialized talent across drug development, manufacturing, regulatory, and commercial functions.
Types of Projects We Support
Regulatory Changes
FDA, EMA, and global agency transitions, new guidance implementation, and submissions support
Mergers & Acquisitions
Quality system integration, due diligence, and post-merger harmonization across sites
Technology Transfers
Drug product and drug substance transfers, process scale-up, and site-to-site transitions
Remediation & Consent Decrees
Warning letter response, 483 observations, and FDA enforcement action support
New Product Launches
NDA/BLA/ANDA filings, commercial readiness, and go-to-market execution
Quality System Buildouts
GMP compliance programs, QMS implementation, and gap assessments
Audit Preparation
FDA PAI readiness, EMA inspections, and internal quality audit support
Facility Startups
Greenfield manufacturing sites, equipment qualification, and cGMP commissioning
Industry Verticals
Quality
- Quality assurance & engineering
- GMP compliance
- CAPA & deviation management
- QMS implementation
- Batch record review
- Supplier qualification
Regulatory
- NDA / BLA / ANDA submissions
- FDA / EMA compliance
- Labeling & advertising review
- Regulatory strategy
- CMC regulatory support
- Post-approval changes
Technical Engineering
- Process & Automation Engineering
- Cleaning Validation
- Process Validation
- Method Validation
- Equipment Validation
- Utilities & Facilities Engineering
Project Management
- Program & project management
- Clinical & commercial launch
- Cross-functional team leadership
- Stage-gate & milestone tracking
- Risk & issue management
- Change control
Request a Pharmaceutical Consultant
Need specialized pharma talent in quality, regulatory, technical engineering, or project management? Fill out the form and we'll find the right person, fast.
