TURNING OUR VISION IN TO HEALTH
A holistic approach
During the development cycle, there are many interfaces that require proactive planning and management. QUANTUNG Pharma offers a holistic approach to bring innovations to market, ensuring an end-in-mind process with seamless integration on all necessary aspects and steps of the development.
Today, the development and marketing of pharmaceuticals is a highly complex undertaking, not only involving several distinct disciplines, work streams and procedures but often also covering multiple countries or regions. The economic success of pharmaceutical companies heavily depends on their ability to make the right decisions regarding their marketing strategy and how they transform their vision into efficient operations.
Pre-submission meetings
In many cases it is advisable to request input from health authorities in the form of Scientific Advice or Pre-Submission Meetings. Once the clinical development program has been established, Clinical Trial Applications, including all required documentation (IB, IMPD/IND) and necessary correspondence with Health Authorities and Ethics Committees, needs to be managed in a way that is consistent on a global scale and driven by scientific and economic considerations. Any specificities such as Orphan Designations, Adaptive Pathways and distinctions regarding pediatric patients (PIP, PSP) need to be factored in as early as possible to avoid any negative impact on development timelines and costs.
Planning, preparation and submission of the application dossier in all targeted jurisdictions
From a business perspective NDAs, BLAs and MAAs are best prepared using a maximum of synergies which, again, requires smart and careful planning well ahead of starting the actual work. Storyboarding exercises may commence during clinical phase still and continue to be a central topic throughout the preparation of a compelling dossier, which is both globally consistent and locally adapted in a finely balanced way. An aspect easily neglected until the 11th hour is the compilation, e-readiness and publishing of a fully compliant eCTD through the appropriate electronic gateways and platforms. Underestimation of these final steps in a pharmaceutical submission often leads to missing internal or external deadlines associated with delays in market access.
