“Effectively Collect Real World Evidence for Early Access Programs”. We have asked Stuart a few questions to reflect on the topic …
We are experts in providing medicines access in markets where you do not plan to launch your drugs or which sit outside of your initial launch markets
An Unlicensed Distribution Agreement with Inceptua allows Pharmaceutical companies to make their approved medicines available in countries where they are not yet approved or commercially available.
Pharmaceutical companies can make their products available through Named Patient Pathways after they have obtained regulatory approval in at least one other country.
Demand for access may exist globally outside of the core launch markets, so Named Patient Pathways can be used to provide open-ended access through one single partner.
Usually on an exclusive basis in each territory, Inceptua can be your one single, trusted partner for the reliable and compliant provision of medicines into territories where the medicines has not yet launched or in countries and regions where the medicine will never be commercially available.
Why Inceptua:
1. Access to markets allowing Pharma companies to sell their products in (120 + territories) and 1000’s of potential customers globally
2. Experts in establishing pricing strategies for an unlicensed medicine aligned to a company’s global pricing and market access approach
3. Support patients and physicians in finding reimbursement for an unlicensed medicine in a specific country, where funding is available
4. Compliant strategies and tactics to build awareness of your program
Ask our experts
About
Mark has specialized in access programs for over 12 years and leads Medicines Access.
About
With over 20 years of industry experience, Stuart leads the consulting arm of our Medicines Access team.
About
With 20 years experience in the pharmaceutical industry, Ruth leads the implementation of our pre-approval access programs.
About
Kelly has 25 experience in regulatory affairs and quality assurance, 10 of which specializing in Medicines Access regulations
Typically, there are three ways in which patients can get access to a medicine; through a clinical trial, when it is commercially available, or via
The regulations governing earlyl access (expanded access, compassionate use, named patient supply etc.) are constantly being
As an agile, global, and robust provider of medicines access programs for the biopharmaceutical industry, Inceptua is uniquely positioned to safely
