WHO WE ARE

About Us

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.

Read More

OUR SERVICES

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

ADDING VALUE

  • Price and reimbursement for healthcare products and services

  • We bring together :

    A thorough understanding of healthcare systems and its decision makers

    Expertise in the interpretation of complex data sets

    Access to health service costing and activity data (Belgium)

HM3A VIVACTIS

Since July 2018 HM3A has integrated Vivactis Group, which operates in 20 countries across the world with a presence in the major markets of the European Union and the USA.
Vivactis Group
Countries Served throughout the world
Offices worldwide
People Through the Agencies
People Through the Network

MEET THE TEAM

WORDS OF THE TEAM

LATEST NEWS

CONTACT US

info@hm3a.eu

Mail Contact

+32 (0)2 733 97 60

Tele Contact

+32 (0)2 733 41 70

Fax




Are you a real person ? Please, answer the question. + 83 = 87