Unlocking Operational Excellence
“Production and Quality management maturity is key to maintain operations efficiency, produce high quality products in compliance with regulations, avoid supply chain interruptions, and guarantee constant growth.”
About Pharma Strategic Solutions
Focus
Pharma Strategic Solutions, LLC provides services to the Pharmaceutical, Biotechnology, Cell and Gene Therapy, and Medical Device industries. We evaluate each client's needs with a strong focus on compliance and cost-effectiveness, delivering tailored strategies that drive success—on time and within budget.
Our Team
Pharma Strategic Solutions selects professionals with the appropriate education, expertise, and experience tailored to each client's needs—delivering high-value solutions and ensuring the successful achievement of goals.
Our Vision
Our Vision
To be a trusted and innovative partner in delivering high-quality, compliant, and science-driven pharmaceutical services—empowering our clients to bring safe, effective, and accessible therapies to patients worldwide.
Our Services
Quality Systems
Project Management and Engineering
Project Management and Engineering
- Quality Operations
- Change Management
- Risk Management
- Investigations, LIR and CAPA Systems
- Batch Records Review and Disposition
- Supplier Qualification Program
- Incoming Materials
- CMO Program Management
- Complaints Management and Recalls
- Stability Programs
- Shipping Studies
Project Management and Engineering
Project Management and Engineering
Project Management and Engineering
- Manufacturing and Packaging Equipment Installation
- Single Use Technology and Isolators
- HVAC and Utilities
- Temperature Mapping
- Control Systems and BMS
- Preventive Maintenance and Calibrations
- Pest Control Program
- EBR and E-Logbooks
- Turn Over Packages
Validations
Project Management and Engineering
Validations
- C&Q (Equipment, Utilities, Facilities)
- Process Validation and PPQ
- CSV Life Cycles
- Validation Master Plans
- URS, DS, FAT, Protocols
- Validation Assessment and Periodic Review
- Cleaning Validation
- Worst Case Determination
- Hold Time Studies
- Cold Chain Qualification
Compliance
Project Management and Engineering
Validations
- Remediation
- 483's and Warning Letters Responses
- Audits (Internal, Regulatory, Suppliers)
- Quality Agreements
- Data Integrity (ALCOA+, 21 CFR Part 11)
- Environmental Monitoring Program
- Supply Chain and Distribution
- Quality Council
- Quality Metrics