Technology Transfer
Build Your Own Diagnostic Manufacturing Facility
BioTical empowers governments, NGOs, and private companies to establish local rapid diagnostic test production — reducing import dependence and improving health security.
Discuss Your ProjectWhat We Deliver
Complete Factory Setup
Turnkey greenfield facility design and build-out, or brownfield retrofit of existing manufacturing spaces.
Production Line Transfer
End-to-end transfer of lateral flow, ELISA, IFA, or other diagnostic manufacturing processes.
Staff Training
Structured curricula for production operators, QC analysts, supervisors, and facility managers.
GMP & Regulatory Guidance
ISO 13485 preparation, CE marking, WHO prequalification, and local regulatory submissions.
Quality Management Systems
Design and implementation of document control, CAPA, risk management, and internal audit programs.
Manufacturing Optimization
Lean manufacturing, yield improvement, OEE analysis, and cost-reduction initiatives post-launch.
Implementation Roadmap
Our structured 7-phase approach from assessment to commercial production.
Needs Assessment
2–4 weeksSite audit, capacity planning, regulatory landscape review, and technology selection.
Facility Design
4–8 weeksClean-room layout, equipment specification, utilities design, and regulatory dossier preparation.
Equipment Procurement
8–16 weeksSourcing production machines, QC instruments, packaging lines, and all ancillary equipment.
Installation & Qualification
4–6 weeksIQ/OQ/PQ validation, equipment commissioning, and environmental monitoring setup.
Process Transfer
6–10 weeksSOPs, formulation transfer, analytical method validation, and pilot production runs.
Staff Training
4–6 weeksHands-on operator training, QC protocols, GMP awareness, and management systems.
Commercial Launch
OngoingRegulatory submission support, post-launch QA audits, and continuous improvement.