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Solvias provides expert physical, chemical, and performance characterization to elucidate the critical quality attributes (CQA) of your small molecule drug. We ensure a seamless transition from early-phase characterization data into a commercial-ready control strategy and validated QC method panel.
Our comprehensive technical capabilities include:
for solid state and particle characterization, including physicochemical properties, dissolution (galenic testing), structure elucidation, (impurities, thermodynamics, kinetics, and foreign particle identification.
with HRAM-LC-MS/GCMS for screening and identification/structure elucidation (impurities), and (HRAM)-LC-MS for cGMP validation and quantification, and cGMP data evaluation.
from early clinical development to full commercialization, ensuring compliance with regulatory standards for IND submission, NDA submission and commercialization, and FDA and EMA guidelines. We perform aerodynamic performance characterizations for pressurized metered dose inhalers (pMDI), nebulizers, nasal sprays, dry powder inhalers (DPI), and soft mist inhalers (SMI). For generic products, we offer in vitro bioequivalence studies meeting all regulatory standards for swift ANDA application preparation and submission.
We can design effective analytical development and control strategies to guide your parenteral drug product from preclinical stages to commercialization. Our experience with all major container closure systems enables us to effectively address unique challenges in the development of parenteral drugs and combination products.
We develop cost-effective analytical development and control strategies, utilizing synergies in method expertise and drug substance/drug product understanding to reduce risk and timelines.
Specific capabilities for small molecule characterization include:
Chemical
- Excipient testing
- Degradation product testing
- Impurities testing
- Enantiomeric purity determination
Physical
- Appearance / color / turbidity / morphology testing
- Moisture content testing
- Particle size assessment
- Leak rate assessment
- Device function assessment
- Identification and characterization of foreign particulates
- Microscopic evaluation
- pH / osmolality / density / viscosity testing
- Heterogeneity / distribution assessment
Performance / Container Closure System / Device
- Delivered dose uniformity testing
- Aerodynamic particle size distribution assessment
- Spray pattern testing
- Plume geometry testing
- Droplet size distribution assessment
- Break loose and glide force testing
- Container closure integrity testing
- Drug-device compatibility testing
- Extractables & Leachables testing
Dosage Form
- Dissolution profile testing
- Disintegration testing
- Hardness tests
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