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Typically, customers of sagaem are:
- Small/medium European pharmaceutical companies without a direct presence in Italy
- EU-wide regulatory and pharmacovigilance (PV) service providers located abroad
- Small domestic companies having no internal regulatory affairs or business development staff
- Italian subsidiaries of marketing pharma companies based in other European countries wishing to outsource most of their functions
Small/medium European pharmaceutical companies without a direct presence in Italy [menu]
- sagaem handles registration procedures for human medicinal products, esp. the national phase of applications submitted through MRP or DCP where Italy is a CMS, from translation into Italian of product information texts up to the grant of Marketing Authorizations (MAs)
- Local assistance for all license maintenance activities can be outsourced to sagaem, e.g. submission of variations to the MAs and their follow-up, including publication in the Official Journal (Gazzetta Ufficiale)
- sagaem offers advice and support on fees payable to the Italian authorities
- sagaem is able to search for potential Italian domestic partners for license or distribution agreements possibly involving the transfer of the MA
- Assistance in negotiations with the marketing partner up to the signature of license and supply agreements is offered by sagaem
- For those companies wishing to set up a direct presence in Italy, sagaem can provide comprehensive advice and operational support until the start-up local branch is fully operational
EU-wide regulatory service providers located abroad [menu]
- sagaem acts as the local partner of big pharma regulatory providers, ensuring a continuous liaison with AIFA and a timely update on Italian rules and procedures
- Pricing and reimbursement (P&R) negotiation with AIFA is a key step to be managed, either before or after the issuance of the MA: the whole procedure, from the draft of the P&R dossier to direct attendance at the negotiation meetings, can safely be outsourced to sagaem.
- Thanks to the expertise recently gained, selected members of sagaem team can act as Local Safety Officers (LSO) for Italy in the name of international pharma companies, ensuring that PV systems are locally in place in order to safe guard public health and maintain compliance with applicable regulatory requirements. The LSO monitors domestic Adverse Drug Reaction (ADR)/Adverse Event (AE) for all locally marketed products and acts as the named person for PV as required by national regulation.
- For CE-marked medical devices, sagaem is able to fulfill pre-launch national obligations, particularly the product registration in the Italian Ministry of Health database in accordance with the Ministerial Decree 20 February 2007 as subsequently amended
Small domestic companies having no internal regulatory affairs or business development staff
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- Domestic companies with a limited product portfolio may need to outsource their regulatory function: sagaem can fulfill the full range of regulatory duties, from the draft of administrative documents needed for the submission of applications up to the notification of the final official decision by the competent authority
- For small domestic companies wishing to enlarge their portfolio sagaem can search for available product opportunities from foreign developers (e.g., CTD dossiers of generic products to be registered in Italy)
- Companies interested in the acquisition of an existing marketing authorization can outsource to sagaem the due diligence of the technical/regulatory product documentation
- sagaem can ensure full compliance with a wide range of regulatory obligations concerning medicinal products, e.g. “bollini” stickers ordering and traceability, annual submission of medical reps listing (January) and statement of promotional expenses (April), enforcement of bilingualism rules
- sagaem, as a third party service provider, is able to support customers in fulfilling their pharmacovigilance obligations and in getting their organizations registered with EudraVigilance. Furthermore, having successfully completed the EudraVigilance knowledge evaluations, properly trained sagaem's staff can perform on behalf of the customer the electronic transmission of:
- Individual Case Safety Reports (ICSRs) and ICSR acknowledgements in the context of clinical trials and post-authorization of medicinal products;
- eXtended EudraVigilance Product Report Messages (XEVPRMs) for the submission of the information on medicines in accordance with Article 57(2), second subparagraph of Regulation (EC) No. 726/2004.
- For food supplements, sagaem provides the necessary advice and support (e.g., product notification to the Ministry of Health, assessment of compliance of labeling texts, composition and claims with national rules)
Italian subsidiaries of marketing pharma companies based in other European countries wishing to outsource most of their functions [menu]
- To survive in a challenging and competitive scenario, start-ups (typically: local subsidiaries of small/medium pharma companies headquartered in other EU countries) may need to reduce their own infrastructure to the minimum possible extent, thus outsourcing most of their functions. Besides regulatory support, sagaem can offer tender management services therefore helping to successfully market hospital generic products even without promotional support
- sagaem can take care of the compliance of promotional material and congress sponsorship in accordance with national rules
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