Technology
A precision-engineered drug–device combination platform designed for speed, reliability, and regulatory success across trauma and CBRN emergency medicine applications.
A New Standard for Emergency Drug Delivery
The RapiGenes autoinjector platform is purpose-built for emergency and military medicine, where every second matters and every dose must be delivered correctly under the most demanding conditions.
- Single-step operation: remove cap, press, done — no training required
- Auto-retracting needle mechanism for needlestick safety (ISO 23908)
- Prefilled, sealed drug cartridge — ambient or cold-chain configurable
- Tamper-evident cap with audible confirmation of actuation
- Ruggedized housing rated for extreme temperature and impact environments
- Compatible with lyophilized biologics, aqueous small molecules, and viscous formulations
- Human factors validation per FDA guidance and IEC 62366-1
- Designed for cGMP manufacture per 21 CFR Parts 210/211 and 820
Drug-Device Interface
Our platform accommodates diverse therapeutic payloads through a standardized cartridge interface. The primary container material selection process includes full extractables and leachables (E&L) assessment per ICH Q3E guidelines and container–closure integrity (CCI) testing.
Drug compatibility studies are conducted in parallel with device design verification, ensuring no late-stage surprises during combination product registration submissions.
Engineering Excellence Across Every Dimension
Human Factors Engineering
Formative and summative usability studies conducted per FDA Human Factors Guidance (2016) and IEC 62366-1. Designed for use by untrained personnel under stress, in PPE, and in reduced-visibility conditions.
Device Design History File
Comprehensive DHF maintained per 21 CFR 820.30 (QSR) and ISO 13485. Design inputs, outputs, verification, validation, and risk management per ISO 14971 fully documented for regulatory submissions.
Drug Master File Integration
Platform designed to support co-submission of a Type III Drug Master File (DMF) covering container-closure system, with appropriate bridging studies to the specific drug product NDA or BLA submission.
Formulation Flexibility
Cartridge platform accommodates aqueous injections, reconstitutable lyophilized products (dual-chamber), and high-viscosity biologics.
Manufacturing Readiness
Design-for-manufacturability (DFM) integrated from concept stage. CMO partnerships established for clinical-scale and commercial-scale production.
Lifecycle Management
Post-market surveillance plan, complaint handling system, PSUR, and PMCF protocols established for ongoing regulatory compliance.
Designed for Regulatory Success
Combination Product Designation
Request for Designation (RFD) submitted to FDA’s Office of Combination Products (OCP) to confirm primary mode of action and lead center assignment (CDER or CBER). Drug-led combination product pathway confirmed.
Drug Product Registration
Investigational New Drug (IND) application covering the combination product, including device description, human factors data, container-closure, and drug–device compatibility data as integral sections of the IND CMC module.
Quality Management System
QMS implemented per FDA Quality System Regulation (21 CFR Part 820) and ISO 13485:2016 covering design controls, CAPA, document control, and supplier quality for both drug and device components.
Government Procurement Pathway
Products developed for CBRN applications are aligned with BARDA’s Medical Countermeasure (MCM) procurement frameworks and DoD’s Chemical and Biological Medical Systems (CBMS) requirements for SNS inclusion eligibility.