IntelGenX
Nualtis is a company dedicated to revolutionizing drug delivery through innovative oral film technology. They leverage science and innovation to develop and manufacture oral thin films that improve therapeutic outcomes, enhance patient experiences, and provide significant advantages over traditional dosage forms. With over two decades of pioneering in oral film technologies and more than 30 patents in the US, Nualtis offers proprietary platforms for human and animal health, partners with pharma leaders, and provides comprehensive services from R&D to manufacturing and regulatory support.
Industries
Nr. of Employees
small (1-50)
IntelGenX
Products
Human therapeutic oral film platform
Platform for developing human therapeutic oral thin films intended to enable faster onset, improved bioavailability, and patient-friendly administration without water.
Veterinary oral film platform
Platform for palatable, room‑stable oral films designed for animal dosing to simplify administration and ensure therapeutic intake.
Human therapeutic oral film platform
Platform for developing human therapeutic oral thin films intended to enable faster onset, improved bioavailability, and patient-friendly administration without water.
Veterinary oral film platform
Platform for palatable, room‑stable oral films designed for animal dosing to simplify administration and ensure therapeutic intake.
Services
R&D partnership and prototype development
Collaborative development services including prototype co‑design, taste‑masking experiments, PK and stability studies, and generation of regulator-ready data.
cGMP manufacturing and scale-up
Pilot through commercial cGMP production of oral films with full QA release and serialization support for large‑scale unit campaigns.
Analytical method development and stability testing
In‑house analytical laboratory services providing method development, validation, and ICH-compliant stability programs.
Regulatory authoring and submission support
Preparation of regulatory master files and submission dossiers for FDA, EMA, and other global agencies; end-to-end submission support.
Licensing and commercialization support
Licensing of existing film-based product candidates and commercial partnership development from concept to market.
R&D partnership and prototype development
Collaborative development services including prototype co‑design, taste‑masking experiments, PK and stability studies, and generation of regulator-ready data.
cGMP manufacturing and scale-up
Pilot through commercial cGMP production of oral films with full QA release and serialization support for large‑scale unit campaigns.
Analytical method development and stability testing
In‑house analytical laboratory services providing method development, validation, and ICH-compliant stability programs.
Regulatory authoring and submission support
Preparation of regulatory master files and submission dossiers for FDA, EMA, and other global agencies; end-to-end submission support.
Licensing and commercialization support
Licensing of existing film-based product candidates and commercial partnership development from concept to market.
Expertise Areas
- Oral film drug delivery
- Formulation development and taste-masking
- Transmucosal/mucoadhesive delivery
- GMP manufacturing and scale-up
Key Technologies
- Orally dissolving thin‑film technology
- Mucoadhesive/transmucosal delivery systems
- Controlled‑release film matrices
- Taste‑masking formulation methods