Grupo Farmasierra´s R&D&I area has separate zones for the analysis, galenic development, industrial scaling and preparation of medicines for clinical trials.

Analytical Development Lab
In strict compliance with Good Laboratory Practices (GLPs), the laboratory has state-of-the-art analytical equipment in high-resolution liquid chromatography, HPLC, UPLC (Ultra Performance Liquid Chromatography), Visible/UV spectroscopy, NIR and atomic absorption, as well as dissolution tests.

The Analytical Development Laboratory conducts the development and validation of analytical methods, in vitro release studies and in vitro in vivo correlation and stability studies under ICH conditions.

Galenic Development Laboratory
     The laboratory has the equipment needed to design and implement      the following manufacturing processes: mixing, granulation,      compression, hard gelatine capsule filling, solid dosage forms      coating, dosing in sachets and blister packaging of different      materials.

     The laboratory has the equipment needed for the design and      execution of the following manufacturing processes: creams      preparation, gel manufacturing, liquid forms formulation and tube      filling.

     The laboratory is properly equipped to determine the following      characterisation trials according to the European Pharmacopoeia:      physical characterisation of mixtures and granulates, weight control,      weight uniformity and average weight of dosage forms and hardness,      friability and disintegration trials.

Pilot plant and Industrial Scaling
The Company has a zone for pilot batches and conducting industrial scaling tests suitably equipped with: mixers, compressing machines, hard gelatine capsules filling machine, sachet filling machine, blister pack machines, bottle filling machines, tube filling machines and vial filling machines.

Preparation of Medicines for Clinical Trials
Farmasierra Manufacturing S.L., a Grupo Farmasierra company authorised by the Spanish Medicines Agency (AEM) to prepare medicinal products for clinical trials (Investigational Medicinal Products, IMP) has special areas for preparing solid and liquid forms to do so.

We offer a comprehensive service for preparing medicines for clinical trials. This service includes:

The Quality Assurance Department oversees operations and the strict adherence to work protocols (manufacture of bulk and intermediate products, containers, labelling and end packaging).

Solid Forms Preparation Zone
Approved dosage forms:

Equipment for preparing solid forms:

Liquid and Semisolid Forms Preparation Zone
Semisolids:


Equipment for preparing liquid and semisolid forms:

Each activity area has a work team who have been trained and are skilled in the various techniques related to analytical control, galenic development technologies, preparation of medicinal products for clinical trials, industrial scaling and assistance in manufacturing processes.

The analytical methods and manufacturing systems used in all development work are reviewed and contrasted to verify the quality, robustness and viability of industrial-scale production.