Confidence Beyond Compliance

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 take the right decisions regarding their marketing strategy and how they transform their vision into efficient operations.

During the development cycle, there are many interfaces that require proactive planning and management. PharmaLex offers a holistic approach to Global Procedure Management, ensuring an end-in-mind process with seamless integration of all necessary aspects and steps of the development.

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 as well as Ethics Committees need to be managed, in a way that is consistent on a global scale and driven by scientific and economic considerations alike. 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.

The next milestone is the 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.

And of course, by far the journey is not over. After the approval of the application the marketing phase begins, with all the necessary tasks associated with a successful life cycle maintenance to ensure product compliance, including variations, renewals, pharmacovigilance duties and potential line extensions and globalization efforts.

With a proven track record of successful applications of a great variety of pharmaceutical development projects PharmaLex is able to provide tailored Global Procedure Management Solutions for the above scenarios, utilizing its concept of Global Reach and Local Presence.

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