Built for Partners Who Need More Than a Manufacturer
Full-Pipeline OEM Capability
From raw antibody formulation through final packaged kits — we own and control every stage of production in-house, eliminating subcontractor risk.
Global Regulatory Expertise
Our regulatory team prepares CE-IVD technical files, FDA 510(k) dossiers, ANVISA registration packages, and country-specific submissions on your behalf.
Precision Customization
Sensitivity thresholds, sample matrix formats, cutoff adjustments, package language, and insert design are all configurable to your market's specific requirements.
Long-Term Partnership Model
A dedicated key account manager, quarterly business reviews, and proactive lifecycle management ensure our relationship scales as your business grows.
PARTNERSHIP MODELS
Four Paths to Bringing Your Diagnostic Brands to Market
OEM Private Label
Validated BioTeke products re-branded and packaged under your label. The fastest path to market with minimal development risk.
Regulatory-cleared base products Custom carton, pouch, and IFU design CE marking transfer support Low MOQ per SKU
Joint IP development programs for novel biomarkers or new diagnostic platforms. For partners with clinical insight seeking a manufacturing and R&D counterpart.
Milestone-based project timelines Shared or licensed IP arrangements Joint regulatory strategy Clinical validation design support
Our manufacturing and quality systems are audited annually against international standards, giving every OEM partner access to a compliance backbone that would take years to build independently.
ISO 13485:2016
Medical devices quality management system
CE-IVD Marking
European Union market authorization
FDA Registered Facility
510(k) cleared products available
GMP-Certified Production
Verified cleanroom manufacturing
Built for Trust
PARTNER SUCCESS STORIES
How BioTeke Partners Grow Their Diagnostics Business
European Union · Distribution Partner
A European medical supply company wanted to differentiate their product line with a multi-pathogen respiratory test. BioTeke delivered a 5-in-1 kit (COVID/Flu A/B/RSV/ADV) with CE-IVD marking in 4 weeks, enabling the partner to capture early-season flu demand.
A chain brand laboratory required a freeze-dried HPV, UTI, STIs qPCR kits with private-label packaging. BioTeke's team completed formulation, stability validation and compliance documentation within 12 weeks.
