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Technology Transfer
Technology Transfer (TT) Solutions
Seamless & Compliant Transfers for Pharmaceutical & Life Science Industries
At Isha’s GMP Consultancy, we specialize in Technology Transfer (TT), ensuring smooth and efficient transfers of products and processes across development, manufacturing sites, and global markets. Our team of industry experts supports you in planning, executing, and managing technology transfers while maintaining regulatory compliance and operational efficiency.
Our Expertise in Technology Transfer:
- End-to-End TT Management – From development to commercial production
- Regulatory Compliance – Aligning with FDA, EU GMP, ICH, and WHO guidelines
- Risk Mitigation – Addressing technical, regulatory & operational challenges
- Customizable TT Strategies – Tailored to your production & technology needs
Comprehensive TT Services
Product & Process Transfer Strategy
- Development-to-Production & Site-to-Site Transfers
- Risk Assessment & Gap Analysis
- SOP Development & Compliance
Technology Transfer Documentation
- Raw Material Specifications – Quantities, sources & safety data sheets
- Process Details – Critical steps, time cycles & process flow charts
- Facility Requirements – Environmental conditions & classification per stage
Quality & Compliance Support
- GMP Compliance & Regulatory Alignment
- In-Process Control Techniques & Parameters
- Stability Study Protocols – Ensuring product integrity & shelf life
Process & Analytical Validation
- Process validation protocols with three consecutive successful batches
- Analytical method validation to meet pharmacopoeial standards
- Troubleshooting deviations in raw materials or process parameters
Storage & Supply Chain Management
- Special storage conditions for raw materials, in-process & finished products
- Ensuring supply chain integrity & quality assurance
Training & Knowledge Transfer
- Hands-on training for operating personnel on product technology & SOPs
- Workshops & documentation support for in-house technical teams
Timeframe for Technology Transfer
- 6 Months per Product (Excluding Stability Studies)
- Timelines depend on material availability & site readiness
Get in touch with us today! Let us help you achieve a seamless technology transfer while maintaining regulatory compliance and operational excellence.