Quality today implies more that having a Quality Assurance and Quality Control department in place The modern concept of Quality defines a company culture which involves all divisions, people and activities from the very first contact with the potential partner, on to the technology transfer phase, through production, project management and subsequent continuous process improvements.

While the FDA concept of Quality-by-Design is quite new and modern, Helsinn has applied a Total Quality approach from middle 90’s.

Four key elements have been identified to be Helsinn’s unique and established approach.

World class Technology Transfer , Regulatory Support and consultant services

Excellent Development and Manufacturing Sites

Commitment to Partnership relationship management

World class Technology Transfer , Regulatory Support and consultant services

These Services are fundamental in modern pharma contract manufacturing. Technology Transfer is a modern concept applied in very different areas. The same applies for Regulatory Support and management of the CMC part. Helsinn’s deep and well-established experience in these areas, is highly appreciated by our partners from large, medium to small pharma companies. To view how Helsinn developed these competencies and the resulting advantages to our partners click here.

Excellent Development and Manufacturing Sites

Helsinn recognizes that need for continuous upgrading and updating of the manufacturing sites is essential to be successful in today’s changing business environment. The investments of recent years in containment for API and HPAI (High Potency Active Ingredients) manufacturing and in upgrading plant capacity has confirmed to the market place the successful leadership of Helsinn Chemical Operations, despite being a small player in the pharmaceutical fine chemicals arena. Click here to see more details.

Commitment to Partnership relationship management

Last but not least, the critical success factor to ensuring that all the above elements are running properly is people: both in Helsinn and in its partners. Helsinn’s Chemical Operations accounts for a large number of highly educated employees (master or Ph.D.) and invests heavily in their continuous education with both, internal and external training. Each manager has his own education plan and top management is committed to ensuring that this is performed. This brings know-how and innovative new ideas to the company and is highly motivating for the staff. On top of that, the relationship management with our partners has been strengthened and improved in the recent years and monitored with a “partnership satisfaction survey”. The positive outcome was not surprising but a confirmation that Helsinn has moved in the right direction in the area of “peer-to-peer” contact and communication between both parties (QA with QA; R&D with R&D,….) that is not only enhancing the quality of the communication being between specialist but builds deep human relationships that bring real added value to the NCE being developed and supplied for clinical phases of commercial supply.