Technology transfer is the critical bridge between scientific discovery and real-world application. Whether moving from R&D to GMP manufacturing, scaling a nanoparticle formulation, or transitioning to a commercial production site, our consulting services ensure every transfer is seamless, reproducible, and regulatory-ready.

We specialize in end-to-end technology transfer for nanomedicines, sterile injectables, and advanced drug delivery systems. Our deep industry experience enables us to anticipate challenges, align stakeholders, and deliver successful transfers that meet FDA and global standards.

Our Technology Transfer Services

1. Manufacturing Scale-Up and Process Transfer

We ensure smooth transfer of formulation and process knowledge from development labs to pilot or commercial manufacturing. Our support covers both internal and third-party CDMO environments.
Includes:

• Transfer protocol design and execution
• Process mapping and critical parameter identification
• Equipment matching and tech compatibility assessment
• Batch-to-batch reproducibility and optimization

2. Analytical Methods Transfer and Validation

Transferring analytical methods requires precision and consistency. We guide you in method qualification, re-validation, and compliance across receiving facilities.
Includes:

• Method validation protocol review
• Qualification of analytical instrumentation
• Transfer of HPLC, DLS, UV, LC-MS, and particle sizing methods
• Data integrity and documentation alignment

3. Documentation and Training Support

A successful transfer hinges on strong documentation and knowledge dissemination. We support technical writing, SOP development, and cross-team training initiatives.
Includes:

• Master batch records and tech transfer packages
• SOPs, deviation reporting, and change control
• Cross-functional team alignment and training programs
• Project management and documentation tracking

4. Regulatory Compliance and Audit Preparedness

Our approach ensures each transfer is executed under a compliant framework aligned with cGMP, ICH, and FDA expectations.
Includes:

• Tech transfer documentation audit-readiness
• Support during regulatory inspections or partner audits
• Risk assessments and mitigation plans
• Compliance gap analysis

Why It Matters

• Time-to-market: Avoid costly delays through structured, documented, and well-managed transfer protocols
• Product quality: Ensure consistency, purity, and safety across batches and facilities
• Regulatory confidence: Be inspection-ready with fully traceable transfer activities
• Partnership success: Build confidence with CDMO, CRO, or strategic partners through professional and transparent execution

Transfer With Confidence

Your innovation deserves a transfer process that protects its integrity, accelerates its readiness, and meets global standards. Let’s ensure your science moves forward without compromise.

📧 Contact us to schedule a consultation and explore how we can support your next technology transfer project.