These are the details for the profile Providing research programs in solid state chemistry..
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A Contract Research Organization (CRO), based in Romania, providing research programs (polymorph/ salt/ co-crystal/ amorphous solid dispersion screening, crystallization studies) to pharmaceutical companies. The research programs are mainly screening & selection of solid forms as well as scale-ups to grams scale. The CRO, also focuses on advanced materials and catalysis, is looking for pharmaceutical companies interested in outsourcing and services agreements.
The Romanian Contract Research Organization (CRO) support pharmaceutical Research&Development programs helping customers to bring drugs into the market in the most efficient way. The services are focused on items related to solid state pharmaceuticals, pre-formulation and formulation of solid dosage forms.
The standard research programs include:
- Polymorph, salt and co-crystal screening;
- Production, quantification and stabilization of amorphous phases;
- Pre-formulation studies (e.g. determination of solubility, dissolution rate – function of pH, pKa and logP/D determinations)
- Crystallization studies, crystallization optimization and scale-up, max. 30-50g active pharmaceutical ingredient (API);
- Pre-clinical studies of solid forms (e.g. tablets, capsules, semi-solids) excepting preparation of the product in final form;
- Advanced analytical studies including high throughput (HT) - X-Ray Powder Diffraction (XRPD), thermal analysis: Differential Scanning Calorimetry (DSC), Thermo-Gravimetric Analysis (TGA), High Performance Liquid Chromatography (HPLC), Nuclear Magnetic Resonance (NMR), Infrared (IR), Raman, polarized light microscopy (PLM) and many others.
The CRO uses state-of-art equipment & lab facilities to provide high quality solid-state solutions at very competitive prices, saving your company money and effort.
The Quality Management System has been recognized to be in full compliance with ISO9001:2008 standards, following an external audit carried out by Germanischer Lloyd Systems Certification. All the work is done according to and is in direct accordance with International Conference on Harmonization (ICH) Q8, 9 and 10 guidelines. Also, the CRO is an approved laboratory for the quality control of medicines according to GMP (Romanian Medicine Agency) – European re-testing.
In fact, the CRO is interested in outsourcing and services agreements with pharmaceutical companies in order to bring better drugs to the market.
• state-of-art instrumentation for solid state characterization
• expert understanding level of project results
• great scientific value supporting patent protection
• great understanding of customer needs
• high flexibility, and great communication
• quick turn-around of project results
• reduced risks and costs for the overall drug development process
All Intellectual Property Rights of the research belongs to the partner.
Pharmaceutical companies, generic or innovative, developing small molecules medicine interested in the solid forms of the compounds, under research outsourcing or services cooperation agreements.
The company is working with medium size pharmaceutical companies in Europe & North America