ALTEN brings to Portugal a strong offer related with Manufacturing, Quality and Regulatory for the Pharmaceutical Industry, building a commercial relationship with 10 distinct clients over the last 12 months.
On the Manufacturing side, we are hiring and training engineers in GxP so we can deploy services in the shop-floor. As example of these kinds of activities we are proudly supporting some of the major Portuguese manufacturing sites in areas such as qualification of equipment, facilities and processes. We are also designing, building and validating automation systems using GAMP5.
On the Quality & Compliance side, we are working with Quality Assurance departments in topics such as QMS maintenance, deviation & CAPA management, complaints management, change control management, process validation, data integrity, audits (internal and 3rd party) and pre-inspections audits. Our clients are not only manufacturing sites but also commercial branches of international labs that need local support. We also have activities related with Quality Control Labs where our experts in Good Laboratory Practices support activities such as method validation and analysis reviews.
Finally, for Regulatory topics ALTEN Portugal relies on the important support of AIXIAL, the Group CRO, for developing end-to-end clinical trials. Besides, we are also addressing the local Regulatory Affairs market with consultants skilled in Market Authorization submission, variations and renewals, CMC maintenance and eCTD publishing. The team is also clients with typical Pharmacovigilance activities such as Pharmacovigilance Quality Systems design and deploy, Risk Management Plans, SAR, PSUR and PASS reporting.
Pharmaceutical industry is by design a sector where knowledge about regulatory constraints coming from as GxP, Eudralex and 21 CR Part 11 are a sine qua non condition to work in the field, hence the reason why in ALTEN we push every day to create more competences in these areas.