HM3A Vivactis is a consultancy agency specialized in market access for pharmaceutical and medical devices.
Our small core of five partners, accrued together more than 200 years of experience and expertise.
Based in Brussels, Belgium with a core business in the Benelux, we networked throughout Europe.
This extensive network allows us to work with leading experts in all important strategic therapeutic areas.
MARKET ACCESS SERVICES
- Strategic counsel on best access route and price strategy
- Payer research: in depth knowledge & insight on how payers perceive value
- Price determination: determine optimum price point according to economic and international criterias & price filing
- Reimbursement: preparing and filing reimbursement dossier
PUBLIC & GOVERNMENTAL AFFAIRS
- Create a favorable environment in which companies can foster their treatments for patients in Belgium through :
– Shortening duration for market access
– Improving reimbursement conditions
– Ensuring best pricing conditions taking into account corporate guidelines
REGULATORY AFFAIRS & RISK MANAGEMENT SERVICES
- 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
"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."