Vivactis HM3A is a consultancy agency specialized in market access for pharmaceuticals, medical devices, vaccines and diagnostics.
We are a small core of dedicated partners and consultants, having accrued together more than 200 years of experience and expertise.
Through our extensive network, we work with leading experts in all important strategic therapeutic areas.
Since July 2018, HM3A Vivactis is member of Vivactis Group.
Vivactis Group is the world’s largest independent consulting group delivering services across the whole pharmaceutical value chain.
MARKET ACCESS SERVICES
- Strategic counselling: we guide our clients to the best access route and pricing strategy. We built market access strategies enabling faster patient access to therapies.
- Payer research: we compile in depth knowledge & insights on how payers perceive value
- Price determination: we prepare and file national pricing dossiers. We set prices for optimal access and returns according to economic and international criteria.
- Reimbursement: we prepare and file reimbursement dossiers
- Health economics capabilities: we build Cost-Effectiveness Models (CEM) and Budget Impact Models (BIM) and run Cost-Effectiveness Analysis (CEA) and Budget Impact Analysis (BIA)
PUBLIC & GOVERNMENTAL AFFAIRS
- Create a favorable environment in which companies can foster their treatments for patients globally through :
– Shortening duration for market access
– Improving reimbursement conditions
– Ensuring best pricing conditions taking into account corporate guidelines
REGULATORY AFFAIRS & RISK MANAGEMENT
- Consultancy – assistance – preparation – submission – follow-up of marketing authorization under the types of application (NP, MRP, DCP, CP) & the different possible formats (e-CTD, NeeS, Paper)
- Preparation of specific sections of the MAA dossier
- Preparation of reports and expert statements
- Preparation – translation – approval – revision of texts for SPC, PIL & Labelling
- Maintenance activities for MAH (renewals, variations, extensions, MAH transfers, etc)
- Risk Management Plan & Risk Management Activities preparation – submission – follow-up related to the FAHMP Agency
- Medical Need Program & Compassionate Use development – preparation – submission
Countries Served throughout the world
People Through the Agencies
People Through the Network
- Costa Rica
- Czech Republic
Dr. Marc CZARKA
Dr. Christian HUYGHE
Dr. Jacques GOLDSTEIN
"Innovation is the core business of human mankind."
"Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity (WHO’s Constitution: principles). Access to therapy, including through social security and insurance systems is a part of health. This is how HM3A’s experience and expertise can contribute improving health and healthcare."
"We can be your link between research and access for the patients."
"Accessibility to innovative therapeutics is our aim therefore collaboration with our clients and partners is our duty to be successful."
"Allow access to the European and local medicines market through our support with regulatory and administrative procedures at the relevant institutions."