| CIRTEC provides product development, analytical chemistry and regulatory consultancy for the development and registration of drug delivery, combination devices, and biological products. Our staff is experienced in all aspects of R&D, Quality, and FDA and ISO regulations required to obtain successful regulatory approvals for these products. |
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| Process Development - Chemistry |
| Coating and Hydrogel Technologies |
| Novel Drug Delivery / Eluting Technologies and Products |
| Pre-formulation and Formulation Technologies |
| Analytical Method Development / Validation and QC Tests per GLP/cGMP |
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- Sterilization process development (ETO, Gamma, chemical, e-beam)
- Special ETO process development (low temperature, RT)
- Development of process challenging devices
- Medical-grade material qualifications
- Cleaning validation with various assays (TOC, GC-MS, etc.)
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- Management of biocompatibility testing
- Cleanroom manufacturing for clinical trials
- Analytical method development, validation, and quality control testing
- Preparation of the chemistry, manufacturing, and controls section for drug and combination device filings
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- Drug coating on metal surfaces
- Dip coating of biopolymers (Gel) on metal surface
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- Modification of metal surfaces
- Development and Manufacturing of various hydrogel systems
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- Ultrasound mediated drug delivery systems
- Control released drug delivery systems
- Inhalation drug delivery systems
- Nano-suspension drugs
- Micro-encapsulation, emulsion, and dispersion techniques
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- Lyophilization of pharmaceuticals
- Drug release profile testing (Dissolution testing/HPLC/UV)
- Drug Delivery Process Monitor via soft X-ray microscope
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- Pre-formulation tests (pKa/LogP, solubility, stability, moisture sorption, DSC/TGA, polymorphism, particle size, compatibility)
- Liquid formulation for oral or injection dosing
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- Solid dosage formulation (immediate and controlled release)
- Formulation-related Tests (dissolution test/HPLC/UV, stability studies under heat, humidity, photolysis and oxidation)
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- HPLC/UV-Vis, UV-Vis, GC/MS/MS, Headspace-GC/FID/MS/TCD, SPME/GC, FT-IR, LC-MS/MS, IEC, TOC, KF titration, XRPD, DSC/TGA, dissolution test, UPLC
- Particle characterization (count and size distribution ) (liquid suspension, aerosol) by static and dynamic light Scattering, light obscuration, Coulter, and Anderson Cascade Impactor
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- Compendium assays (heavy metal, carbon content, etc.)
- Stability testing, cleaning validation, volatiles and leachables
- Flow Cytometry
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