A biomaterials R&D lab, from design to regulatory submission
Take your material from design and formulation to regulatory submission through our biomaterials R&D lab, or bring us in for any step: optimization, competitive analysis or performance testing.
Discuss a pilot studyBiomaterials R&D Services
We support your program from formulation design through to regulatory submission, or at any step along the way.
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Design and formulation
Hydrogel synthesis, collagen, PLA, PLGA and PGA, 3D bioprinting and encapsulation.
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Dissolution and release testing
Drug release, extractables and leachables.
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Fluid handling and degradation
Free swell, absorbency under load (AUL) and MVTR, plus enzymatic, accelerated and hydrolytic degradation.
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Rheology and mechanical
G′ and G″, tan δ, viscosity, modulus and frequency sweeps, plus compression, tensile and yield stress.
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Predictive AI and ML models
Formulation-to-characterization models, in vitro to in vivo correlation, and research across literature, patents and regulation.
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Custom automation design
Test instruments and fixtures designed and built around your method.
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Regulatory submission support
Get GLP-aligned data and reports built to support your regulatory submission.
Your data and IP stay yours
Every dataset, formulation and invention from your studies with GelTech Labs belongs to your team.
Sample forms we work with
- Powders
- Films and sheets
- Tablets
- Injectables
- Microparticles
- Amorphous gels
- Foams
- Implants
Regulatory submission support
Take your material to submission with data and reports built for your regulatory pathway, from methods aligned with the standards reviewers expect.
Talk to us about your pathway- Regulatory and application pathway guidance
- Methods aligned with ASTM, ISO and USP
- Data and reports to support your submission
Quality and compliance
Give your quality team data it can use through testing, software and data handling aligned with the standards it works to.
- GLP-aligned testing
- ISO 17025-aligned services
- 21 CFR Part 11-aligned software
- ISO 27001-aligned and SOC 2 Type 2-aligned data security
- ASTM, ISO and USP-aligned methods
Plan your study
Tell us the material and what the data needs to show. The first consultation is on us.