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Avogadro
Avogadro is an independent GLP, GMP compliant CRO established in 1998 and based in Toulouse, France and Cambridge MA, USA.
Avogadro specializes in Pharmaceutical Analysis, CMC&RA, Quality Control, In-life Phase Studies, Bioanalytical Chemistry, Drug Metabolism, Pharmacokinetics, ADME, Biochemistry, Residues and TAS.
Avogadro provides R&D services for human and veterinary pharmaceuticals, cosmetics and nutraceuticals.
Phone:
+33 (0)5 62 14 73 14
Fax:+33 (0)5 62 14 73 10
Email:avogadro@avogadro.fr
Website:http://www.avogadro-lab.com
Address:Parc de Génibrat 31470 FONTENILLES
+33 (0)5 62 14 73 14Fax:
+33 (0)5 62 14 73 10Email:
avogadro@avogadro.frWebsite:
http://www.avogadro-lab.comAddress:
Parc de Génibrat 31470 FONTENILLES- USA
- France
ANALYTICAL
API Type
Service Type
DeformulationMethodsMethod DevelopmentMethod TransferMethod ValidationOphthalmic Formulation/PackagingReference Standard CertificationStructure ElucidationTests - Dissolution/DisintegrationDisintegrationDissolution App. I/IITests - Impurities/DegradationForced DegradationImp./Deg QuantitationTests - PhysicalParticle SizeParticulate MatterPhysical TestingTablet Hardness/FriabilityTests - Protein/Peptide/DNA/OligoElectrophoresisElisa/Western BlotPeptide mappingProtein Aggregation/DeaggregationProtein Carbohydrate AnalysisProtein Chemical StabilityProtein Dosage FormTests - StabilityAccelerated StabilityICH/Commercial Stability StorageICH/Commercial Stability TestingPhotostabilityStability Storage (I/II)Stability Testing (I/II)Tests/Analysis - OtherAssay/PotencyChiral Separation/AnalysisComparator AnalysisCompendial TestingContent UniformityExtractables/LeachablesFourier Transform Infrared Analysis Investigative AnalysisLCMS AnalysisMetals AnalysisMoistureMolar Extinction Coefficient DeterminationResidual Ethylene OxideResidual Solvent AnalysisSample AnalysisThermal Analyses/DSCTrace AnalysisX-Ray powder diffraction analysisTets - ReleaseIn-vitro release testingLot and Batch Release TestingTopical Formulation/Packaging CompatibilityWet Chemistry
BIO-ANALYTICAL
CLINICAL DEVELOPMENT
Clinical Study Type
CONSULTANT
FACILITY REGULATORY STATUS
Facility subcategories
PHARMACOKINETICS
Formulation Given
PREFORMULATION
Preformulation Services
Accelerated StabilityBulk and Tap DensityExcipient CompatibilityForced Degradation StudiesFTIRHygroscopicityMelting PointMicroscopyMoisture ContentOsmolarityParticle size measurements Partition CoefficientpH-Rate profilesPhysical PropertiesPkaRheology/ViscositySolid State CharacterizationSolubilityThermal Analyses/DSC
REGULATORY
Formulation Category
Regulatory Services
General Properties
| Size of the Facilities (square feet) | 20000 |
| Number of People | 45 |
Equipment
| Equipment | Check if exist |
|---|---|
| HPLC | |
| LC-MS | |
| GC | |
| NMR | |
| Solid State NMR | |
| DSC | |
| TGA | |
| FTIR | |
| NIR | |
| Raman | |
| UV-Vis | |
| PXRD | |
| Particle Sizer | |
| Karl Fischer |
HPLC Stability Indicating Methods Developed for Oral formulations (last 3 years)
| Activity/Phase | Oral Tablet | Oral Liquid | Oral Softgel Capsule | Oral Hard Gel Capsule | ODT |
|---|---|---|---|---|---|
| Preclinical | 2 | ||||
| Phase I – II | 12 | 3 | 1 | 2 | |
| Phase III –commercial | 7 | 5 |
HPLC Stability Indicating Methods Developed for Injectables (last 3 years)
| Activity/Phase | Injectable Solution | Injectable Lyophilized | Injectable Depot | Stents |
|---|---|---|---|---|
| Preclinical | 1 | |||
| Phase I-II | 8 | 7 | ||
| Phase III-Commercial | 6 | 3 |
HPLC Stability Indicating Methods developed for other formulation types (last 3 years)
| Activity/Phase | Tox Supplies | API | Topical, semi solids, gels | Transdermal Patch | DPI | MDI | Nasal | Ophthalmic |
|---|---|---|---|---|---|---|---|---|
| Phase III-Commercial | 6 | 5 | ||||||
| Preclinical | 45 | 6 | 6 | 1 | ||||
| Phase I-II | 6 | 9 | 2 | 3 |
Dissolution and Drug Release Methods Developed/Validated (last 3 years)
| Activity/Phase | Oral Solid IR | Oral MR Tablet | ODT | Oral Chewable / Gum | Transdermal Patch | Drug Eluting Stents |
|---|---|---|---|---|---|---|
| Preclinical | ||||||
| Phase I-II | 12 | 6 | 4 | |||
| Phase III-commercial | 8 | 3 | 4 |
General Properties
| Size of the Facilities (square feet) | |
| Number of People | 5 |
The number of INJECTABLE dosage forms developed in-house within the last three years
| Activity/Phase | Injectable Solution | Injectable Lyophilized | Injectable Depot | Injectable Suspension | Injectable Emulsion | Liposome |
|---|---|---|---|---|---|---|
| Preclinical | 2 | 1 | 1 | |||
| Phase I – II | 2 | 1 | ||||
| Phase III –commercial |
The number of OTHER dosage forms developed in-house within the last three years
| Activity/Phase | Topical/Gel-Cream-Ointment | Transdermal | DPI | MDI | Stent | Nasal | Ophthalmic |
|---|---|---|---|---|---|---|---|
| Preclinical | 1 | ||||||
| Phase I – II | |||||||
| Phase III –commercial |
Technology Capability
| Check if exist | |
|---|---|
| Aseptic Fills | |
| Sterile Hand-Fills | |
| Non-Sterile Fills | |
| Terminal Steam Sterilization | |
| Irradiation | |
| Chemical Sterilization | |
| Lyophilization | |
| Blow-Fill Seal | |
| Homogenization | |
| OEB-5 Handling |
Equipment Capability
| Lab Scale | Pilot Scale | |
|---|---|---|
| Compounding vessel | ||
| Compounding vessel jacketed | ||
| Receiving vessel | ||
| Vial washer | ||
| Depyrogenation oven | ||
| Autoclave | 1 | |
| Filler | ||
| Capper | ||
| Freeze Dryer | 1 | |
| Production |
