Unlocking Operational Excellence
Production and quality management maturity is essential for maintaining operational efficiency. The use of Electronic systems, batch records and E-logbooks in combination with an efficient Training program helps avoid supply chain interruptions, ensures high quality products and constant growth.
About Pharma Strategic Solutions
Focus
Pharma Strategic Solutions, LLC offers specialized services to the Pharmaceutical, Biotechnology, Cell and Gene Therapy, and Medical Device sectors. We assess each client's specific needs with a keen emphasis on compliance and cost-effectiveness, providing tailored strategies to achieve short and long term value. Our focus on production a
Pharma Strategic Solutions, LLC offers specialized services to the Pharmaceutical, Biotechnology, Cell and Gene Therapy, and Medical Device sectors. We assess each client's specific needs with a keen emphasis on compliance and cost-effectiveness, providing tailored strategies to achieve short and long term value. Our focus on production and quality systems efficiency ensures successful projects accomplishment delivered 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 in areas like electronic batch records, electronic logbooks, validations and compliance while enhancing quality systems and ensuring successful accomplishments 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 utilize strategies improving quality systems, facilitating remediation and validation processes, and ultimately bringing 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
- Electronic Batch Record & E-Logbooks Implementation and Management
- Supplier Qualification Program
- CMO Program
- Customer Complaints
- Product Recalls
- Stability Programs Implementation & Management
Project Management and Engineering
Project Management and Engineering
Project Management and Engineering
- Manufacturing and Packaging Equipment Installation
- Single Use & Isolator Technology
- HVAC and Utilities
- Temperature Mapping
- BMS & Control Systems
- Preventive Maintenance and Calibration Programs
- Pest Control Program
- Turn Over Package
Validations
Project Management and Engineering
Validations
- C&Q (Equipment, Utilities, Facilities)
- Process Validation and PPQ
- CSV lifecycles
- Validation Master Plans
- URS, DS, FAT, and Protocols Development
- Validation Assessment and Periodic Review
- Cleaning Validation, worst case determination and hold time studies
- Cold Chain Qualification and Shipping Studies
Compliance
Project Management and Engineering
Validations
- Remediation
- 483's and Warning Letters Responses
- Audits (internal, regulatory and suppliers)
- Quality Agreements
- Data Integrity Principles (ALCOA+ and 21 CFR Part 11)
- Environmental Monitoring Programs
- Warehouse Compliance
- Quality Council
- Quality Metrics