The Helsinn model is based on three pillars:
2) developing products and obtaining the marketing authorization on international markets
3) out-licensing products through a network of highly qualified partners worldwide.
A strong compliance system is required to gain access to the pharmaceutical market. Regulatory requirements vary across Health Authorities worldwide, and each step, beginning from the very start of the product development process, requires careful planning of the compliance components, starting from Good Laboratory Practices (GLP) in the pre-clinical experiments and ending with Post Marketing Surveillance in the commercialization phase.
Helsinn Group has built a full integrated compliance system based on a strong Quality Assurance System that guarantees full respect of every Good Laboratory Practice (GLP) requirement, a Regulatory Affairs department able to coordinate filings on a worldwide basis and a Drug Safety department which coordinates Post Marketing Surveillance activities for all of its partners around the world. Helsinn's manufacturing plants are committed to health, safety and environmental protection.
Moreover, special attention is paid to the growth of our pipeline with a strong Intellectual Property Protection system, from technological platforms to product patents. Helsinn’s proprietary trade names are also licensed to our partners for the various markets.
In the current challenging environment, access also means health economics, pricing and reimbursement in order to provide patients and social partners with pharmaceuticals products representing real value. The Market Access department contributes to this important effort.
The Art of Access is the Art of Compliance, and reflects Helsinn's ethical contribution to patients' health, safety and quality of life.