Orphan drugs

Newly dedicated services to Orphan Drugs

Your virtual set up in Europe, fully committed to patients, offering cash on order service at variable costs

Orphan drugs services

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 a business unit to support pharmaceutical industry and biotech to introduce newly approved and innovative products destined to limited patient population.

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.

We are ready to offer Project Management on Program Implementation.

Company set up

  • 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

Commercial operations

  • 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
  • Project Management Implementation
  • ID patient tracking on behalf on Controlled
  • Full service provided on variable costs

Secondary Packaging

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

Locations

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

Warehousing

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

Stock Management

  • 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

Logistic Services

  • 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 Management

In-bound / Out-bound

  • Inbound Storage and Picking
  • Outbound shipment with reliable long lasting carrier 

Pharmacovigilance

  • Pharmacovigilance activity and rule compliance on demand
  • Post marketing surveillance

Regulatory and Pharmacist support

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

Authorizations

  • GDP available
  • European fully owned WHL authorized
  • ISO 9001:2008 procedures in place in Milan and Naples
  • “Restricted Products” , i.e. narcotic drugs and blood derivate authorization and procedures in place

Tendering activity

  • Participation to National and Regional tenders on demand 
  • Targeting interest on National and Regional Bid on demand

Customs Clearance

  • Import procedures 
  • Relationship with Customs Authorities
  • Compliance to customs rules and Health Authorities

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