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
Departments
Regulatory & Market Access
Departments
-
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
Departments
Communication and Marketing
Departments
-
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





