Galenic pharmaceutical development
Request a quoteWe carry out the galenic development of different pharmaceutical forms, adapted to customer needs and drug requirements.
Galenic development is an initial and essential part of pharmaceutical development, for which the following is carried out:
- Pre-formulation studies.
- Galenic development of innovative, generic and OTC drugs.
- Galenic design and development of new dosage forms.
- Compatibility studies on APIs and excipients.
- Design of manufacturing processes.
- Technology transfer.
- Expert reports.
- Study of Patents.
We have the following facilities and equipment for our developments:
Solid pharmaceutical forms:
- Rotary and eccentric compression machine.
- High-speed V mixer.
- Granulator
- Fluid bed
- Coating pan
- Capsule filler
- Extruder / Spheroniser.
- Spray-dryer.
- Freeze-dryer.
- Voluminometer.
- Rotolab.
Liquid and semi-solid pharmaceutical forms:
- Paddle stirrer.
- Ultra-Turrax homogeniser.
- Colloid mill.
- Rheometer.
- Viscosimeter.
- Osmometer.
Control Equipment:
- Analytical balance and moisture analyser.
- Durometer.
- Friability tester.
- Disintegrator.
- Dissolution test equipment and fraction collector.
- Granulometric analysis equipment based on laser diffraction and Coulter.
Other Equipment:
- Biosafety cabinet.
- Differential Scanning Calorimetry (DSC).
- Blister packaging machine.
- Pharmaceutical laboratories.
Certifications and Accreditations
The Pharmaceutical Development Control Laboratory is certified by the Spanish Agency for Medicines and Healthcare Products (AEMPS) in Good Manufacturing Practice (GMP) guidelines: Physical and chemical quality control medicines for human use and medicines under research.
The manufacturing plant is certified by the Spanish Agency for Medicines and Healthcare Products (AEMPS) in Good Manufacturing Practice (GMP) guidelines: Manufacture and import of pharmaceuticals for non-sterile human use, including psychotropic and narcotic substances / Manufacture and import of non-sterile investigational medicinal products.
The drug manufacturing plant has been granted the ISO 13485 certification for quality management for the medical devices industry.
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