Quality Control includes three Labs: chemical-physical controls, microbiological and packaging materials analysis.
While using equipments at high technology level, quality control avails itself of qualified and expert professionals, who can guarantee the best chemical-physical controls aligned with the current European Guidelines.
- Chemical and physical controls (HPLC – GC – Titration – IR – PSD – Dissolution – CCIT.. )
- Microbiological controls ( Microbiological count – LAL – Sterility)
- Packaging materials controls
- Stability Studies
- Micro and chemical analitical methods validation and transfer
Research and Development
Our R&D Team, with a strong technical expertise, is actively involved in several activities such as:
- Analytical method development (HPLC, GC, CCIT, PSD and others)
- Forced degradation studies
- Drug product physical/chemical characterizations
- Lab scale/Technical preparations
- QbD approach
- Stability studies
Our Quality Assurance and Quality Control units are composed by a great team of technicians with experience in the field of international guidelines for the safety and reliability of the drug.
EU GMP Certificate for Pharmaceutical Products
GMP Certificate for Veterinary Products
UNI EN ISO 9001:2015
Quality Management System
CQ ISO 13485
Medical device quality system