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YOUR VIRTUAL SET UP IN EUROPE,

FULLY COMMITTED TO PATIENTS,

OFFERING FROM ORDER TO CASH SERVICE AT VARIABLE COSTS

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Petrone Group sets up virtual organization, taking the burden of any fixed cost and leaves pharma, biotech companies any direct promotion efforts to Institutions, Doctors and Patient Associations.

We have established two business units to support pharmaceutical industry and biotech to introduce the Unlicensed Drugs and the newly approved and innovative products destinated to limited patient population: the Orphan Drugs.

Petrone Group offers services from our fully authorised and approved branches, providing commercial and administrative settings at any of our locations for marketing launching your innovative drug.

We are GDP authorised, fully owned WHL authorised and ISO 9001:2008 procedures in place in Milan and Naples. In addition, we can manage “Restricted Products”, i.e. narcotic drugs and blood derivate authorisation and procedures in place.

We can offer tendering activity ON DEMAND and targeting National and Regional Bid.

We are ready to offer Project Management on Program Implementation.

Our Custom Clearence activity goes from import procedures to compliance with customs rules and Health Authorities.

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  • European location settings
  • Legal Entity establishment
  • Chamber of Commerce inscription and dealings
  • Minimum capital requirement settings
  • National compliance to Fiscal rules
  • Account control management
  • P&L statements
  • Financial statements and reporting

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  • Full back-office  provider
  • Multi language Customers service (collecting orders accepting and execution) – emergency plan.
  • On line linkage to client/supplier, on-line statistics figures.
  • Order to Cash to Hospitals and Institutions
  • Credit collection
  • Direct Invoicing system
  • ID patient tracking on behalf on Controlled Health Authorities Regime
  • Project Mangement Implementation
  • Full service provided on variable costs

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  • Secondary packaging facility approved in Italy
  • In- house leaflet supplier company

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  • Distribution centers in 3 countries
  • 29,350 mq² covered surface
  • 15.639 tons moved every year
  • Own real estate

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  • Stock Management, Handling, Pick & Pack
  • Management of Temperature controlled and refrigerated drugs
  • Quarantine Management
  • Storage of “Restricted Products”

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  • Claim management
  • Lot traceability
  • Batch recall management
  • Stock evaluation and drugs tracking
  • Monitoring of activities through key indicators tracking of deliveries
  • Processing and delivery of statistics

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  • In-bound Storage and Picking
  • Out-bound shipment with reliable long lasting carrier

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  • Numbered Stickers “Bollini” Management
  • Full traceability system in compliance to Italian regulations
  • Cross docking management
  • Temporary storage and in transit management
  • 24/48 hours national delivery
  • Emergency Plan Managem

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  • Pharmacovigilance activity and rule compliance
  • Post marketing surveillance

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  • Direct contact  with National Regulatory Authorities
  • Dossier  and Technical File Submission on demand
  • Marketing Authorization  and CE maintenance

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UNLICENSED DRUGS

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This business unit assists in introducing drugs such as:

-innovative line EMA registered but still under National Registration process,

-under L. 648/96 regimes,

-under Compassionate Use,

-Off-labels

-under Clinical trial or

-under Adaptive Registration Procedures

We do accelerate and facilitate the patient access of pharmaceutical products in Italy, Spain and Ireland through our own location since Approval Day One and BEFORE.

We provide support with NOS applications.

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ORPHAN DRUGS

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Orphan Drugs and Rare Diseases Treatment Program and Drugs under Special Regime needs dedicated personnel, highly experienced and continuously supportive actions.

We do accelerate and facilitate the market access of newly approved pharmaceutical products in Italy, Spain and Ireland through our own location since Approval Day One.

Between our references, there are various of the mostly innovative companies in Europe and worldwide.

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