GMP compliance and regulatory expertise
Pharmaceutical Project Management Excellence
Our team has successfully managed complex pharmaceutical projects across multiple continents, with experience in solid dose, liquid and sterile manufacturing, cell and gene therapy, API production facilities, and comprehensive GMP 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
"Their project management team's change management strategy and third-party design reviews kept our pharmaceutical expansion fully aligned with evolving FDA requirements."
Manufacturing Company
"The Owner's Team delivered exceptional coordination — from RFP preparation to startup sequencing — ensuring our new production line launched flawlessly."
Generic Manufacturing Entity
"TOT's detailed cost estimating and oversight on budgeting helped us stay under target while maintaining validation integrity across all systems."
Mid-Atlantic Based Global Pharmaceutical Manufacturing Firm
Comprehensive solutions
High-Tech Manufacturing & Data Centers Services
Project Management
- Project planning and scheduling
- Risk management
- Stakeholder coordination
- Budget and cost control
Concept Design
- GMP facility design and layout
- Clean room and HVAC design
- Process utility design
- Containment system design
Process Consulting
- API manufacturing processes
- Formulation and packaging
- Sterile manufacturing systems
- Process optimization
CQV
- IQ/OQ/PQ protocols
- Equipment qualification
- Process validation
- Change control management
Regulatory Compliance
- FDA 21 CFR Part 11 compliance
- GMP facility validation
- EMA and ICH guidelines
- Regulatory documentation
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.
