Regulatory support

Our team of highly skilled and passionate professionals, with over 30 years of experience in dealings with Italian MoH, USMAF, AIFA and Central Narcotic Office, offers a valuable support and consultancy service to the pharmaceutical, medical device and food supplements industry.

We operate across all the GxPs: our team includes Qualified Persons (QP), Responsible Persons (RP), Pharmacovigilance QP-PV, Quality Assurance experts, Supply Chain & Logistic experts to provide support and advice across the business life-cycle.

We are a consistent, ambitious and technically competent company. We genuinely care for clients and provide them with the highest standards of regulatory support with a focus on:

Import applications of Controlled drugs management;
Registration in MoH and AIFA’s web Portals
Ordering antifraud stickers (BOLLINI), pre-printing check, supervising the shipment from the printers to the production site
Handling the collection of data regarding the used and discarded antifraud stickers
Transmission to the database of the Ministry of Health of the information concerning the movements of the packs via XML format as required by the guidelines and the specifications of the Ministry of Health
Updating the database on the number of antifraud stickers remaining with the company
Import application of unlicensed products

Certifications

AUTORIZZAZIONE aAMM-35_2021

CERTIFICATO GMP IT-26-H-2021

AUTORIZZAZIONE UCS 275/2021

Regulatory support

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Certifications

Depo Pack s.r.l.