The Life Sciences industry faces constant challenges. To be competitive, companies must have partners that enable them to improve their efficiency, as well as their ability to innovate. In addition, they should not forget to comply with the most stringent regulatory requirements.
ALTEN SPAIN, thanks to its experience and knowledge of the Life Sciences sector, has a wide offer related to manufacturing, quality and regulation of the pharmaceutical industry. To do this, it strives to create success stories thanks to the knowledge of regulatory restrictions such as GxP, Eudralex and 21 CFR Part 11. These are sine qua non conditions to develop an activity, with the highest standards of demand and satisfaction.
We are proud to join the main Spanish manufacturers in such vital areas as the qualification of equipment, facilities and processes. We also participate in the design, construction and validation of automation systems under GAMP5 methodology. For this, we hire and train engineers in GxP, which enables the deployment of services in the plant.
QUALITY AND COMPLIANCE
Currently, we collaborate with quality assurance departments on aspects such as: QMS maintenance, deviations and CAPAs management, claims management, change control management, process and method validation, data integrity, audits (internal and third parties), etc. In this way, we develop our activity, both in industrial manufacturing plants, and in commercial delegations of international laboratories that need local assistance.
REGULATORY AFFAIRS IN LIFE SCIENCES
ALTEN SPAIN has the support and help of AIXIAL, a CRO company belonging to the ALTEN Group and a benchmark in the French and European markets for the last 15 years. It thereby provides its clients with thousands of hours of experience in the development of clinical trials from start to finish. In this way, it is aimed at the local Regulatory Affairs market with expert consultants in
- The presentation of market authorisations
- Modifications and renewals
- Maintenance of CMC and publication of eCTD
- Design and deployment of pharmacovigilance quality systems
- Risk management plans
- SAR, PSUR and PASS reports