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Our Technology Transfer Management and Services provide complete support for the seamless transfer of analytical methods, manufacturing processes, and product knowledge between development, QC, and production sites. Whether transferring internally between facilities or externally to partners or contract laboratories, we ensure that every aspect of the process is scientifically sound, fully documented, and compliant with global GMP and regulatory expectations.

With a structured, project-managed approach, we minimize risk, maintain data integrity, and ensure analytical and process equivalency across sites. Our team of specialists supports both simple and complex transfers — from single-method verifications to full-scale product introductions.

Comprehensive Technology Transfer Capabilities Include:

  • Transfer Planning & Coordination

    • Development of detailed transfer plans, timelines, and communication strategies

    • Identification of critical parameters, method attributes, and acceptance criteria

    • Coordination between sending and receiving units to ensure readiness and alignment

  • Analytical Method Transfer

    • Comparative testing, method verification, and equivalency assessments

    • Execution of transfer protocols for assay, related substances, dissolution, and other analytical methods

    • Support for remediation, optimization, and troubleshooting during the transfer process

  • Process & Manufacturing Transfer

    • Technical support for process parameter definition, scale-up, and control strategy alignment

    • Review of batch records, process data, and critical quality attributes (CQAs)

    • Support for pilot-to-commercial transition and regulatory submission readiness

  • Documentation & Compliance

    • Preparation of Technology Transfer Protocols and Final Reports

    • Full GMP documentation, traceability, and data integrity assurance

    • Alignment with ICH Q10, WHO, EMA, and FDA expectations for technology transfer

  • Project Management & Oversight

    • End-to-end management of transfer activities from initiation to completion

    • Risk identification and mitigation planning

    • Cross-functional coordination with analytical, QA, and manufacturing teams