Over 60 years’ presence as manufacturer of steroid APIs. Highly skilled experience in custom synthesis’ development from lab trials, through production and commercial scale.
R&D
Biographic research, chemical pathways study and custom synthesis development both for off and under patent APIs.
QUALITY ASSURANCE
Steroid’s quality system operates in full compliance with the Good Manufacturing Practices, regularly audited by local Health Authorities.
QUALITY CONTROL
Regular and customized analytical service provided for any single manufactured API, carried out with all major techniques available.
ANALYTICAL DEVELOPMENT
Long and strong experience in the development and validation of in-house analytical methods.
REGULATORY AFFAIRS
Full support to customers for ASMF submission, DMF registrations and Dossiers preparation or variations.