Pharma Quality and Regulatory Sciences Services

Our Pharmaceuticals Quality and Regulatory sciences services are categorised in three verticals. 

1. cGMP Service
2. Computer Systems Validation
3. Process Scale Up, Validation and Technology Transfer 

cGMP Service

ScientiaBio provides comprehensive, hands-on, Good Manufacturing Practice (GMP) quality and compliance services to the pharmaceutical, medical device, and biotechnology industries. Although the FDA and other regulatory bodies  publishes regulations and guidance documents for industry in the Federal Register, they won’t hold your hand or walk you through the details to ensure you achieve compliance.

Our GMP Consultant’s technical expertise, experience and scalability makes us an ideal partner for your cGMP consultancy work. The result of our efforts is production facilities that are in good condition, equipment that is properly maintained and calibrated, employees who are qualified and fully trained, and processes that are reliable, reproducible, and properly documented.

Our services includes :

1. Strategic consulting for FDA & other regulatory bodies  compliance and quality assurance 

2. Audits

• Due diligence inspection
• Pre inspection support for Sites, GAP analysis
• Site audits
• Vendor / Supplier Audits
• Contract manufacturing site Audits
• Data integrity audits

3. Inspection Readiness 

• Pre inspection support
• Mock inspection
• Mock interview for inspection
• Documentation review

4. Green field project support

• Laboratory design
• Laboratory set up
• GMP training 

Computer Systems Validation

CSV isn’t just a best practice, it’s a regulatory requirements. The global regulatory bodies require CSV process to confirm the accuracy and integrity of data in computerised system in order to ensure product safety and effectiveness. However it doesn’t stop at one time, because validation must be seen as an ongoing process. Each CSV requirement need explicit analysis, validation and objective proof from specialist. 

ScientiaBio has extensive experience with the GAMP5 validation model to ensure that you have the appropriate level of documentation. We customise our CSV services to handle your needs. Our CSV team provide value by bringing a strategic balance of industry experience , technical skills and best practices to the engagement

Our services includes :

1. IT Remote Audits
2. 21 CFR Part 11, GAP Assessment
3. Laboratory Audits and Laboratory automation
4. Data integrity audits
5. Production equipment Automation / Integration
6. Central Batch manufacturing Record Management
7. Process utility equipment  integration
8. Warehouse system integration
9. PLC, HMI, SCADA, DCS, Process Instrumentation, Electrical Control System
10. Installation & Commissioning support services
11. Operational Support at site 
12. Custom Application development
13. Batch Record review and PQR preparation 

Process Scale Up, Validation and Technology Transfer

According to FDA’s Scale-Up and Post-Approval Changes (SUPAC) guidelines, the entire scale-up process must be validated every time the process is scaled-up by a factor of at least 10. As noted earlier, the path from laboratory-scale batches to production-scale batches typically involves factors of 10 — or even 100 times or more — initial amounts.

Our experts have the experience and expertise to provide support services to your scale up operations. Our consultants use critical knowledge and experience in production processes and technologies to streamline process scale-ups and get products to patients on schedule.

Our service include :

1. Streamlining process scale up
2. Process validation in accordance with regulatory and cGMP guidelines
3. Rectification issues likely to result in Form 483’s or FDA warning letters