Our modern facilities allow for optimal galenic and analytical development of drugs, together with stability chambers in all conditions, in order to carry out all kinds of ICH studies.
We provide formulation solutions in different pharmaceutical forms: solids (tablets, capsules), liquids (suspensions, solutions), and semi-solids (gels, creams), among others.
We offer a wide range of analytical services for the pharmaceutical, cosmetic and veterinary sectors.
We have extensive experience in the development of different pharmaceutical specialities, generic drugs and OTC products, addressing entire projects or specific stages of development.
Analytical Development:
- Development studies and validation of analytical techniques.
- Characterisation of the raw materials according to Pharmacopoeia.
- Quantification of active ingredients, impurities and degradation products in raw materials and end products.
- Forced degradation studies.
- Quality control of industrial manufacturing batches.
- In-vitro dissolution profiles.
- Study of the discriminatory power of the dissolution method.
- Transfer of analytical techniques.
- Analysis of metallic impurities by ICP-OES.
Aimed at:
- Pharmaceutical laboratories.
Accreditations and Recognition
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.
