Developing novel medicines on a global scale
Public health emergencies of international concern such as COVID-19 clearly show the significance of fast and efficient processes to develop novel medicines on a global scale. What we at PharmaLex have observed over the past few years is an increasing amount of pharmaceutical businesses aiming to obtain marketing authorization in both the EU and US jurisdictions (or in some cases even additional ones such as China). By obtaining a more or less simultaneous authorization, they benefit from synergies and a remarkably reduced time-to-market.
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. Once a promising drug candidate has entered the late phase of development and a global business strategy evolves, it is time to start thinking about the regulatory applications: the planning, preparation and submission of the application dossier in all targeted jurisdictions.
From a business perspective New Drug Applications (NDAs), Biologics License Applications (BLAs) and Marketing Authorization Applications (MAAs) are best prepared using a maximum of synergies, which requires smart and careful planning well ahead of starting the actual work. Storyboarding exercises may commence during the clinical phase and still 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 eleventh 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 submission often leads to missing internal or external deadlines associated with delays in market access.
Based on our experience with simultaneous submissions over the past decades, PharmaLex has implemented a process that allows our clients to take full advantage of the synergies of parallel submissions while minimizing the risks of non-compliance or delays. The cornerstones of our approach are an expert team with clearly defined and client-tailored roles and responsibilities under a strong global program leadership possessing outstanding scientific as well as local regulatory expertise including New Chemical Entities (NCE), New Biological Entities (NBE), Generics, Biosimilars, Advanced Therapy Medicinal Products (ATMP) and Medical Devices in all major Therapeutic Areas.
With a proven track record of successful applications of a great variety of pharmaceutical development projects PharmaLex is able to provide tailored solutions for the above scenarios, utilizing its concept of “global reach and local presence”. Headquartered in Europe and having a strong team based in the US (and many other countries and regions of interest), we are ideally positioned to assemble a powerful international team of experts under the leadership of an experienced Regulatory Program Leader to navigate you through the intricacies of a complex undertaking such as a parallel submission in two or more jurisdictions.
PharmaLex enables you to get your product to all of your desired markets fast, in a cost-efficient manor whilst minimizing the risks of non-compliance.
Registration Procedures (DCP, MRP, CP, NDA and ANDA)
Former Regulatory Authority Employees on Staff
What our clients say
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VP Regulatory / Quality
I just wanted to relay our sincere thanks to you and the team for two really excellent days training. It was well organized and structured to cover regulatory expectations, GMP principle and routine work challenges of industry. The presenters and moderator were highly skilled in this area to accommodate any queries raised during the training session and were well able to keep the team engaged even in remote/virtual training session. The design of training slides was impressive and the use of technology to make virtual training was remarkable.
Compliance Lead, Qualified Person, Amneal Ireland Limited