In the Vietnamese pharmaceutical industry, now at a pivotal moment in biotechnology, the development of biologics and biosimilars is no longer a distant vision. Yet, many companies continue to face challenges due to limited technical capabilities and the lack of international-standard production processes.

At Tín Dân Corporation, our team of experts recognizes this as the key bottleneck for many Vietnamese companies: from molecule evaluation and factory design to choosing the right production technology. Without a clear strategy and proper technical resources, investing in biological products can be costly and may not achieve the desired results.

We offer a comprehensive solution, combining international experience with a robust technology platform: from GMP consulting and technology transfer to production partnerships and product registration

1. Advanced Tech Consulting for Pharma & Biologics

We provide comprehensive technical services covering the entire lifecycle of pharmaceutical and biologics projects – from concept to implementation and handover.

1.1 Strategic Consulting & Technical Advisory

We analyze needs, assess the current state, and propose suitable technical solutions for each production model (chemical pharmaceuticals, biologics, biosimilars). Our services include investment strategy planning, technology selection, and defining technical standards.

1.2 Conceptual, Basic & Detailed Design

We carry out the full GMP-compliant facility design process, including:

  • GMP layout planning and zoning

  • Design of clean utilities systems: WFI, PW, Clean Steam, HVAC, etc.

  • Fill & finish production line design

  • Design of API, R&D, and aseptic production areas

All designs are fully integrated, optimized for workflow, and compliant with international standards.

1.3 Design Implementation & Technical Support

We provide a team of engineers and experts to collaborate on design execution, resolve on-site technical issues, and adjust solutions according to each phase and area of the project.

1.4 Project Management & Governance

We oversee the entire project lifecycle: planning, progress monitoring, cost control, risk management, and decision support. We also establish governance mechanisms, control processes, and reporting systems to ensure the project operates transparently, efficiently, and according to standards.

🌐 International CDMO/CRO Partnership Support

We connect businesses with reputable manufacturing and research partners, assisting in capability assessment and establishing suitable collaborations.

✔️ CQV – CSV & Quality Management System (QMS)

We perform equipment, system, and software qualification according to GMP/EU-GMP standards, finalize the QMS, and prepare for international audits.

🧬 Bioprocess Know-How

We provide guidance on cell culture, cell line development, and optimization of bioprocess workflows, building the technical foundation for biologics and biosimilars.

🔄 Technology Transfer & Training

We support the transfer of processes from lab → pilot → commercial scale and provide GMP-compliant training for operational teams.

🧪 Supply of Pharmaceutical Materials & Products (DS/DP)

We supply active pharmaceutical ingredients (DS) and finished drug products (DP), including vials, syringes, tablets, etc., to support R&D and production.

🤖 AI-Powered Market Research

We leverage AI to analyze demand, competitors, and market trends, enabling businesses to make faster and more accurate decisions.

2. Specialized Services for Biologicals & Biosimilars

🔍 1. Potential Molecule Evaluation

We perform market and technical analysis to select the most suitable biological molecule for development.

🧪 2. Small-Scale R&D Process Package (1L–10L)

We develop cell culture and purification processes at lab scale to optimize the technical foundation.

⚗️ 3. Pilot-Scale Process Package (50L–200L)

We scale up processes from lab to pilot scale to verify practical production feasibility.

🤝 4. Large-Scale CDMO/CMO Collaboration (200L–2000L)

We connect businesses with international manufacturers to produce clinical trial and commercial batches.

💊 5. Complete DS/DP Supply

  • DS (Drug Substance): biological active ingredient

  • DP (Drug Product): finished product (vials, syringes, etc.)

🧫 6. Cell Banking & Characterization

We create and characterize cell lines, including master and working cell banks.

🏗️ 7. Biological Facility Design & Establishment

We design cleanrooms and GMP-compliant biologics production lines.

🔄 8. Technology Transfer & Technical Support

We support the transfer of processes from lab → pilot → commercial production.

🏛️ 9. Regulatory & Strategic Support (EMA/UK/USFDA)

We provide guidance on documentation, standards, and product registration strategies for international biologics markets.

We offer these services to support businesses across the entire lifecycle of a biologics product: from initial molecule research → development → pilot production → commercialization → international registration.