SERVICES FOR PHARMACEUTICAL COMPANIES
In the new facility inspected and authorized by AIFA we perform chemical, chemical - physical, biological and microbiological quality controls for other companies with particular reference to:
- Sterile products
- Non sterile products
- Biological medicinal products
- Pharmacologically active raw materials
- Vegetal products
- Homeopathic products
- Products destined to clinical sperimentation
The analytical activity regards also medicinal products that are manipulated inside structures provided with systems of primary and secondary physical containment.
Further to quality control, we perfom:
- Stability studies (accelerated, long-term, stress test, in-use test, photostability) with stability indicating methods
- Identification of impurities and of degradation products
- Characterization of microorganisms
- Research of bacterial endotoxins
- Development and validation of analytical methods
- Analytical phase of clinical tests for bioavailability (in GLP)
- Compatibility studies with primary and secondary packaging material and with excipients
Furthermore, we offer technical - scientific and regulatory support to the different qualifications (environmental, raw material, process steps) and to documentative activities thanks to a trained team dedicated to services for pharmaceutical and biomedical companies.