Our Services

Our business covers two main areas of interest for companies activating in the Healthcare and Pharma Markets.

Custom Services for
Regulatory & Market Access
  • Consultancy on authorization of medicines through national, DCP or MRP procedures
  • Consultancy on post-authorization procedures (variations)
    – Preparation of expert reports for Module 3 -Quality and for other quality issues (variations)
    – Preparation of documentation for the authorization of new medicinal products
    – Scientific assessment of pharmaceutical documentation for human medicinal products authorization
    – Preparation of documentation for generic medicinal products development
    – Physical-chemical analytical methods development for medicinal products
  • GMP, PhV and GDP Consultancy
  • Regulatory assessment for advertising campaigns/materials
  • Support activities:
    – Readability testing for Patient Information Leaflets
    – DTP services – PILs, packaging
    – Specialized medical translations
    – Medical writing for marketing purposes
  • Trainings/ courses health product advertising conformity
  • Data collection services for Pharmacovigilance activities:
    – Local medical literature screening (Romania and Moldova)
    – Local medical scientific events monitoring;
    – 24/7 call center system for AE reporting, quality complaints, providing medical information and medicines’ availability
    – Social media and medical forums monitoring for AE reporting
  • QPPV Services
  • ICSR tracking, reconciliation, follow-up
  • Risk Management Plan
  • PSURs (periodic safety update reports)
  • SUSAR reporting
  • DSURs (Development Safety Update Report)
  • PhV Audit support
  • KPI report preparation
  • Reports Management Assessment
  • Defining strategy
  • Consultancy, development and submission of HTA applications
  • Competition evaluation (pricing, reimbursement and HTA)
  • Submission of pricing applications
  • Monitoring of submitted applications
  • Review of Prescribing and Reimbursment Protocols
  • Ensuring communication between the company and authorities
  • Stakeholder mapping
  • Relevant policy assessment
  • HTA trainings/courses
  • Audit of service providers (e.g. laboratories, storage sites, manufacturing sites)
  • Audit of active substance, excipients and packaging manufacturers
  • GxP Training/Courses on specific topics, including regulatory/guideline changes, etc.
  • Audit for the evaluation of the degree of conformity before the NAMMD inspection and consulting for inspection preparation
  • Guidance on understanding the deficiencies received during the inspection and drafting the action plan
  • Consultancy for creating/improving the quality management system
  • Consultancy for various aspects of regulatory interpretation in the two areas (GMP/GDP)
Custom Services for
Communication and Marketing
  • Multi-channel communication strategy and campaign:
– TV / Radio / DOOH: spot concept, copywriting, production, media plan
– Online & Social Media: Website (design, copywriting, implementation), Facebook page (set-up page, posts and promotion), Google AdWords campaigns, Bloggers and Celebrities Campaigns
  • Public Relations strategies
  • Graphic Design, DTP
  • Promotional items production (flyers, brochures, banners etc.)
  • Event planning (concept, strategy, logistics, agenda, speakers, media coverage)
  • General Monitoring
  • TV & Radio Monitoring
  • Online Monitoring
  • Social Media, Forums and Sale/Purchase Ads Monitoring
  • Advertising Monitoring
  • Legislation, Regulation and Public Tenders
  • Daily Digest Report
  • Info Alert Services
  • Online platform
  • Custom reports
  • We have developed a Digital Signage system, currently available in two of the largest private healthcare networks in Romania – Sanador and Medicover (HealthcareTV) and in major pharmacy chains (PharmacyTV).
  • We use the latest generation of digital video displays, set up in the most visible spots of the location.
  • Presently, our network consists of 194 displays; we are constantly expanding our network, thus we estimate a total of 250 displays, by mid 2019.
  • Average monthly traffic: 600.000 – Healthcare TV | 1.000.000 – Pharmacy TV;
  • Captive audience: the LED screens are the only source of information, located in the clients` sight. The TV programme alternates between ads and educational content, thus holding the patients/clients` attention.
  • According to a study conducted by Arbiton & Edison, in JanuaryFebruary 2010, DOOH has the best retention rate – 85%, out of all communication channels (OOH/TV/radio). The customers spend time in front of the monitors without being distracted. Moreover, a custom communication message, adapted to the educational context, contributes to the impact of the campaign.
  • 360medical.ro is an online platform for medical and pharma related news and information
  • Dedicated content for healthcare and pharma professionals
  • Medical news for the general public
  • Main topics: innovation in medicine, medical research, biotechnology, telemedicine, e-health, new molecules and therapies, private and public medical systems in Romania, industry jobs, medical events etc.
  • Exclusive news and interviews

Group Members and Affiliates