Infarmade, S.L.

About

INFARMADE is a Contract Development Organization for pharmaceutical, biotechnology, nutraceuticals and cosmetics industries.

In INFARMADE, we adapt our development and analysis services to your needs, and provide an open channel of communication to make you feel close to your development processes.

COMPLETE DEVELOPMENT OF SOLID, LIQUID AND SEMISOLID DOSAGE FORMS PHARMACEUTICAL

‒ Definition of qualitative and quantitative formulas
‒ Compatibility studies
‒ Forced degradation studies
‒ Efficacy of antimicrobial preservation
‒ Design of the manufacturing process and in-process control

RAW MATERIAL CHARACTERIZATION STUDIES

‒ Raw material particle size analysis
‒ Raw material solubility studies
‒ Identification by IR spectroscopy
‒ Thermal profile by DSC
‒ TGA studies
‒ Humidity content analysis
‒ ICH stability and degradation studies for API

ANALITYCAL DEVELOPMENT

‒ Active substance method
‒ Related substances method
‒ Water content determination (Karl Fischer)
‒ Residual solvents determination
‒ In vitro dissolution profile studies (USP 2, 3 and 4)
‒ In vitro permeability studies
‒ Enantiomeric purity method
‒ In vitro permeation studies with Franz diffusion cells
‒ Microbiological control methods

MANUFACTURING OF PILOT BATCHES

‒ Manufacturing in GMP conditions
‒ Validation of manufacturing processes
‒ Technology transfer

STABILITY STUDIES

‒ ICH stability studies: climatic zones I to IV
‒ Photostability studies: visible and UV radiations
‒ In-use and On-going stability studies

QUALITY CONTROL AND BATCH RELEASE

INFARMADE has the AEMPS authorization to perform the quality control of medicinal products for human use, veterinary use and investigational medicinal products; so much for drugs produced in the EU as for medicines imported from outside Europe.

Likewise, INFARMADE has authorization from the AEMPS for release and batch certification of medicines for human/veterinary and investigational medicines.

Keywords

pilot batch manufacturing, pharmaceutical development, analytical development, quality control & batch release, formulation development, stability studies

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