Business Modules
Business Models
Flexible partnership models for product development
Whether you need a development partner, want to share the risk and reward of a project, or are looking to in-license a product, Auxilla offers three ways to work together, each backed by results achieved since 2019.
01
Contract research services
Partner of Choice
Achievements since 2019
- 14 clients from EU/US
- 3 products approved in US (2 injectables, 1 otic drops)
- 3 products approved in EU (1 injectable and 2 liquid orals)
- 24 products technology transferred (8 liquid orals, 7 injectables, 5 ophthalmics, 4 semisolids)
02
Co-development projects
Shared risk and shared reward
Achievements since 2019
- 6 clients from EU/US/India
- 3 products for US market filed in 2024
- 1 product filed in EU in 2024
03
In-house developed projects for out-licensing
Fulfilling unmet and under-met needs
Portfolio
- 1 complex liposomal injection
- 6 RTU long acting injections
- 1 RTU and 1 PFS injection
Service Modules
End-to-end development support
Our services cover the full development workflow, from pre-formulation to validated analytical methods, quality documentation and microbiological testing.
Module 01
Formulation Development
- Injectable formulations
- Ophthalmic formulations
- Liquid oral formulations
- Liposomal and microsphere-based formulations
- Pre-formulation studies
- Complex generic formulations
Module 02
Analytical Development
- Analytical method development
- Method validation
- Stability studies
- Analytical characterization
- Impurity profiling
Module 03
Quality Assurance & Documentation
- SOP and protocol documentation
- Analytical data review
- Validation documentation
- Development report preparation
- Validation and qualification oversight
- Deviation and CAPA management
Module 04
Microbiology
- Microbial limit testing
- Sterility testing
- Bacterial endotoxin testing
- Environmental monitoring
- Water system microbiological monitoring
- Bioburden testing
- Microbiological method suitability
- Cleanroom microbiological monitoring
From Lab to Manufacturing
Technology transfer through an established CMO network
We collaborate with external contract manufacturing organizations across key dosage forms, supporting the transfer of developed products to manufacturing. To date, 24 products have been technology transferred.
- Injectable vials
- Injectable lyo
- Infusion bags
- Powder filling
- Liquid oral
- Injectable onco
Discuss a contract research or co-development project
Our business development team will respond to your enquiry.