Our
research and development department is made up of 12 extremely well
qualified professionals with many years of experience: 9 staff with
PHDs and 3 technicians. They are subdivided into 3 teams working respectively
in COSMA, AMSA and Milan University.
The
instruments (RC1 Calorimeter,DSC) are capable of evaluating the thermal
risks of components, the chemical reactions and the optimisation of
the procedures.
An
analysis laboratory supporting the R&D department develops analysis
methods, identifying and characterising impurities and performing studies
on stability.
Quality Control System Our quality control team is characterised by
a wealth of experience and competence.
The high quality of our work is also highlighted by the total of more
than 50 APIs in our product list, and more than 200 DMFs , prepared by
AMSA and COSMA and submitted in the most regulated countries, both with
regard to non patented and patented products.
Our Quality Control laboratories are equipped with the most advanced analysis
instruments while our history is characterised by our collaboration with
important clients, leaders in the market.
The most recent FDA inspections: AMSA
2004: no 483
2001: no 483
1998: three minor points on the certificate 483
COSMA
2004: one minor point on the certificate 483
2003: two minor points on the certificate 483
2000: three minor points on the certificate 483
1998: four minor points on the certificate 483