FDA compliance and GMP expertise
Biotechnology Project Management Excellence
Our team has successfully managed complex biotechnology projects across multiple continents, with experience in biosafety level 3 & 4 facilities, GMP-compliant manufacturing, upstream and downstream processes, and comprehensive validation management. We collaborate closely with engineering partners, contractors, and regulatory stakeholders to maintain full alignment with GMP.
Industry Experience
Trusted by industry leaders
What Our Clients Say
"They guided us from concept through operational readiness, ensuring our new biotech facility met GMP standards without a single regulatory deviation."
Solid Dosage Manufacturing Company
"Their cleanroom concept design expertise and process flow diagrams optimized every aspect of our lab operations — improving efficiency and compliance."
Generic Manufacturing Entity
"From cost estimating to commissioning, TOT's project management approach gave us full confidence in timelines, budgets, and technical precision."
Global Biologics Manufacturing Firm
Comprehensive solutions
High-Tech Manufacturing & Data Centers Services
Facility Design
- Clean room design and validation
- HVAC systems for biotech facilities
- Process utility design
- Containment system design
Regulatory Compliance
- FDA 21 CFR Part 11 compliance
- GMP facility validation
- ICH guidelines implementation
- Risk assessment and mitigation
Process Consulting
- Upstream process design
- Downstream purification systems
- Fermentation system design
- Process optimization
Commissioning & Validation
- IQ/OQ/PQ protocols
- Equipment qualification
- Process validation
- Change control management
Project Management
- Project planning and scheduling
- Risk management
- Stakeholder coordination
- Budget and cost control
Safety & Environmental
- Biosafety level compliance
- Environmental impact assessment
- Waste management systems
- Emergency response planning
Your trusted partner
Why Choose The Owner's Team?
Specialized Project Management Office with pharmaceutical industry experience and proven methodologies.
International project delivery across 30+ countries with local regulatory knowledge and cultural expertise.
Comprehensive GMP implementation and validation services with zero regulatory violations across 200+ projects.
Extensive knowledge of FDA, EMA, and international pharmaceutical regulations with proven compliance track record.
