Pharmaceutical
GxP Compliant. Audit Ready. Always.
Pharmaceutical facilities demand the highest standards of compliance, documentation, and quality. MTLI delivers GxP-compliant infrastructure for manufacturing, distribution, and storage operations.
We Understand Your Pain Points
Regulatory Compliance
FDA, DEA, and international regulations require validated systems and documentation.
Serialization
Track-and-trace requirements demand integration with automation systems.
Controlled Substances
DEA-compliant storage with security and access controls.
Temperature Sensitivity
Many products require precise temperature control throughout the supply chain.
How MTLI Solves These Challenges
GxP Facility Construction
Facilities designed and built to pharmaceutical standards.
- Clean room construction
- Controlled environments
- GMP facility design
- Validation documentation
- FDA-ready facilities
Pharmaceutical Storage
Storage systems for pharmaceutical products and materials.
- Controlled storage
- Temperature mapping
- DEA-compliant cages
- Clean room racking
- Serialization integration
Validated Automation
Automation systems with IQ/OQ/PQ documentation.
- Validated ASRS
- Track-and-trace conveyors
- Clean room automation
- Serialization systems
- 21 CFR Part 11 compliant
Pharmaceutical Expertise
MTLI Group brings deep expertise in pharmaceutical infrastructure. We understand your unique challenges, compliance requirements, and operational demands.
- GxP-compliant construction
- IQ/OQ/PQ documentation
- Clean room expertise
- Temperature-controlled systems
- DEA-compliant storage
- FDA audit support
Ready to Get Started?
Contact our pharmaceutical specialists to discuss your project requirements.
Pharma Distributor, DEA-Compliant DC
The Challenge
A pharmaceutical distributor needed a facility to handle controlled substances with full DEA compliance and track-and-trace capability.
The Solution
MTLI constructed a 200,000 SF distribution center with DEA-compliant vault storage, temperature-controlled zones, and serialization-integrated automation.
Results
- DEA Schedule II-V compliant
- Full serialization
- Zero audit findings
- Same-day shipping capability
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Common Questions, Answered
What does MTLI do for pharmaceutical facilities?
Everything between the walls: racking, automation, construction, electrical, installation, relocation, and lifecycle maintenance, delivered as one accountable team. Projects range from under $100K upgrades to $100M+ turnkey programs.
Can you work inside a live pharmaceutical operation?
Yes, that is where we do most of our work. Phased sequencing, off-shift crews, and strict containment keep your operation running, and our record includes a 1,000,000+ sq ft healthcare transition completed with zero disruption.
Do you understand the compliance side of pharmaceutical?
Codes, permits, engineered drawings, and safety standards are handled by MTLI for every project, with certified supervisors on site daily and documentation maintained as we build.
How do we start?
Book a call. A specialist with pharmaceutical experience calls you within one business day, walks the project with you, and delivers an engineered proposal with a real number.
Ready to Transform Your Pharmaceutical Operations?
Contact MTLI Group to discuss your project requirements and get a customized solution.