Bringing Innovations to Market
A holistic approach
During the development cycle, there are many interfaces that require proactive planning and management. PharmaLex 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.
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.
The team behind
With a proven track record for successful applications of a great variety of pharmaceutical development projects, PharmaLex provides tailored planning to bring innovations to the market for the above scenarios, utilizing its concept of Global Reach and Local Presence.
Bringing Innovations to Market Services
PharmaLex’s Global Statistics and Data Science team brings together a wide range of experts – from study design and planning to statistical analysis, reporting and data management. Our experts help companies with complex innovative trial design, translational and precision medicine, pharmacometrics, and data science across the clinical journey.More Info
Clinical Development Services
PharmaLex provides global Clinical Development / Clinical Regulatory expertise to support every step of the clinical development pathway, from first in man studies through registration studies as well as post approval programs.More Info
Clinical Trial Applications
PharmaLex provides support for all aspects of Clinical Trial Authorisation (CTA) and Investigational New Drug (IND) applications and, with clinical regulations continuing to evolve around the world, it is more important than ever to have the right expertise by your side.More Info
Our comprehensive approach meets the holistic needs of start-ups, venture capital funded firms and small to mid-size biotech companies, while our targeted expertise helps large pharmaceutical companies with specialized development strategies needed.More Info
Gap Analysis and Consulting
Place your Pharmacovigilance, Epidemiology, and Risk management activities (PER) in experienced hands. Whether you need an urgent solution for an unexpected problem or are seeking to outsource entire PER processes – our knowledgeable experts will be there for you no matter where you are.More Info
We offer a modular, end-to-end approach to literature surveillance for pharmacovigilance and our experts are flexible enough to offer a tailored solution as well accordingly to client’s requirement.More Info
PharmaLex’s organization ensures global delivery of all PV audit services. We are the first-choice provider of PV audit services for many pharmaceutical companies around the world. At PharmaLex, auditors are highly qualified with necessary and long-standing expierence as well as strong cultural awareness and excellent communication skills to effectively conduct and/or participate in PV audit activities.More Info
Pricing and Reimbursement
Being a global company with an extensive geographical reach, thus far, PharmaLex can carry out these evaluations in Europe, Australia, Canada and US.More Info
Toxicological Services and Risk Assessment
Be it a drug, medical device, cosmetic, consumer product, or food ingredient, we at PharmaLex have mastered the science of toxicological risk assessment and have helped products sail through rigorous regulatory scrutiny and reach the market.More Info
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