E-mail: office@hpss-consulting.com

Phone: +40 373-811-119

Mobile: +40 727-356-986

Domains Activity

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  2. Domains activity
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Market Access

  • Check iconBusiness plan assessment, strategy set-up
  • Check iconIssuing opinions regarding regulations/legislative issues
  • Check iconStakeholder mapping
  • Check iconCompetition assessment (prices, settlement and Health Technology Assessment - HTA)
  • Check iconDrawing up price files
  • Check iconAdvice for drawing up and submitting HTA assessment applications
  • Check iconAccess of medicines to refund lists
  • Check iconMonitoring applications submitted with the competent authorities
  • Check iconEnsuring communication and representation between the company and the competent authorities
  • Check iconCost efficiency studies
  • Check iconLegislation monitoring
  • Check iconSpecialized legal assistance

Regulatory Affairs

  • Check iconAdvice on the authorization of medicines by means of the national procedure, MRP, DCP
  • Check iconAdvice on changes in marketing authorization, line extension, notifications - in line with Directive 2001/83/EC, Article 61 (3), renewal, transfer of marketing authorizations
  • Check iconAdvice on changing the legal status (RX-OTC) of the medicinal product for human use
  • Check iconAdvice on GMP, GPhVP, GDP
  • Check iconAdvice on the approval and implementation of campaigns/advertising materials
  • Check iconAdvice on the registration in the national database of Medical Devices
  • Check iconNotice for placing food supplements on the market with the MH/NRDIFB
  • Check iconAdvice on obtaining the authorization to use last resort treatment
  • Check iconAdvice on obtaining authorization for special needs
  • Check iconLegislation monitoring
  • Check iconSpecialized legal assistance

GxP Advice

  • Check iconAudit of service providers
  • Check iconAudit of manufacturers of active substances, packaging materials and excipients
  • Check iconGxP training/courses
  • Check iconAdvice on preparing the BPD authorisation/certification file for the wholesale distributors of medicines for human use
  • Check iconAdvice for administrative changes (Changes Annexes Wholesale Distribution Authorisation)
  • Check iconAudit to assess the degree of compliance prior to a NAMMDR inspection
  • Check iconAdvice on optimizing the inspection process
  • Check iconAdvice on providing the optimal response to the plan of measures submitted by NAMMDR following the deficiencies found
  • Check iconAdvice on improving the quality management system
  • Check iconAdvice on the interpretation of GMP/GDP regulations
  • Check iconAdvice on obtaining a medical device distributor license
  • Check iconAdvice on preparing the authorization file, changing the holder - legal entity, changing the chief pharmacist, for the community pharmacy for human use
  • Check iconLegislation monitoring
  • Check iconSpecialized legal assistance

Pharmacovigilance

  • Check iconPharmacovigilance audit support
  • Check iconKPI Report Preparation
  • Check iconSUSAR Reporting
  • Check iconPSURs (safety update reports)
  • Check iconQPPV Services
  • Check iconRisk Management Plan
  • Check iconMonitoring for social media and medical forums for SE reporting, scientific events, local medical literature
  • Check iconStandard Operating Procedures (SOPs)
  • Check iconLegislation monitoring
  • Check iconSpecialized legal assistance

Communication and Marketing

  • Check iconRepresentation of the beneficiary before the competent authorities (MH, NHIH, NAMMDR, NRDIFB, PHNI, etc.)
  • Check iconRepresentation of the beneficiary in communicating with healthcare professionals, with the purpose of organizing medical events
  • Check iconRepresentation of the beneficiary in relating with patient associations
  • Check iconOrganizing events for launching pharmaceutical products on the market
  • Check iconOrganizing scientific and commercial events
  • Check iconAdvertising and PR services
  • Check iconDrawing up educational materials needed for media campaigns
  • Check iconMedia monitoring
  • Check iconSupport activities for marketing purposes (specialized medical translations, warning labels, packaging, advertising materials for patients)
  • Check iconLegislation monitoring
  • Check iconSpecialized legal assistance