Optimizing efficiency, product compliance and market coverage globally to locally
With costs and regulatory complexities on the rise, companies are finding it more challenging than ever to maintain mature product revenue streams. In today’s hyper-competitive market, managing a product post-approval requires the support of a seasoned global partner with unparalleled cross-functional and operational expertise. Minimize these challenges with a Global Headquarter Strategic Outsourcing plan.
From discovery to product
Introducing a new drug to market requires a complex interplay of multiple activities and disciplines. For a successful launch, drug developers need a partner that offers holistic solutions and collaborative expertise to help overcome rising R&D costs and growing regulatory complexities. That’s where a disciplined approach, such as Integrated Product Development (IPD), can make the difference.
From submission to commercialization
During the development cycle, there are many interfaces that require proactive planning and management. PharmaLex offers a holistic approach to bring innovations to the market ensuring an end-in-mind process with seamless integration of all necessary aspects and steps of the development.
Regional support and geographic expansion
PharmaLex supports local affiliate needs with a model tailored to specific needs and operating models, ensuring safety and compliance while continuing to meet ever-changing payer and regulatory demands. PharmaLex’s experts work across scientific and medical affairs, quality and compliance, regulatory affairs, and pharmacovigilance and across many different regions. Our services deliver workforce flexibility, streamline processes, and help fill gaps in local knowledge.
Guiding through business transformation
M&A decisions are often made to satisfy shareholder and investor expectations for quick business results. However, adopting a narrow approach to M&A can be costly. A successful strategy must ensure different stakeholders are brought into the M&A process early on, and that functions that lie outside the scope of typical business activities have a seat at the table. Making M&A decisions without considering key functions, such as regulatory affairs, can have a detrimental effect on these departments and on the overall agreement.
From target to implementation
In a fast-changing environment with diverse regulatory frameworks, it is crucial to have the right partner at your side. If you are looking for tailored consulting services that fit your specific needs, the PharmaLex team of strategic and scientific experts is here to help you on your way to success.
When bringing new products to market, there are various complex hurdles to navigate – and that’s where we come in. Our experts are at the forefront of today’s drug development and have a fundamental understanding of the entire lifecycle and beyond. Benefit from 25+ years of global expertise at your fingertips.