Integrated Product Development

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    Forge a strategic asset management partnership on Integrated Product Development

    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 them overcome rising R&D costs and growing regulatory complexities. That’s where a forward-looking approach, such as Integrated Product Development (IPD), can make the difference.

    Going far beyond basic project management, the Integrated Product Development program at PharmaLex represents a partnership between you and our team. Our experts actively contribute to your product’s path to success by integrating nonclinical/clinical, toxicological and crucial biostatistical support with Chemistry, Manufacturing and Controls (CMC) services, regulatory strategy, quality management, compliance support and a well-planned market access approach.

    A bench-to-bedside approach for IPD

    Our team delivers holistic support from discovery to development, preparing everything for a smooth transition to product launch, including clinical and medical writing and guidance and support during critical agency interactions for an integrated product development.

    We understand the importance of integrated collaboration among different functions and stakeholders from the outset. Rather than following a linear approach that addresses the process phase by phase, we integrate the various functional activities of key departments to save you time, reduce risk, lower costs and, ultimately, drive commercial success.

    A target product profile

    Your development strategy must include a clear, well-defined destination—typically a target product profile—that states where your drug fits into clinical practice and the global marketplace.

    Our Integrated Product Development team helps identify and sharpen your target product profile early in the development process to guide the design of an integrated development plan that includes a regulatory/clinical roadmap, strategy and mitigation plan.

    The team behind

    Integrated Product Development is based on a highly collaborative, multidisciplinary approach, working closely with subject matter experts.

    Your Integrated Product Development lead

    At PharmaLex, clients work with a dedicated Integrated Product Development lead who acts as both a strategic lead and project manager. It is their responsibility to make sure your IPD program stays on track.

    Each one of our Integrated Product Development leads is a member of our Global Center for Integrated Development—a network of senior consultants from various PharmaLex service areas with extensive drug development experience.

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    With over 75 CMC consultants across the globe, PharmaLex has substantial CMC expertise across all areas. We are able to offer an integrated solution combining the scientific, technological, non-clinical, clinical and regulatory expertise with our broad global project experience to meet your specific needs, from discovery to licensing and post-approval.

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    CMC strategy and documentation plays an important role from early development to authoring of the marketing authorization application dossier. It also extends to change control and maintenance throughout the product lifecycle. Moreover, CMC requirements are complex and different for chemicals, biologicals, biosimilars, herbals or homeopathics. PharmaLex guides you to the best CMC approach for your products in line with health authority requirements and helps you to stay CMC compliant with sustainable processes.

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    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.

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    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.

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    To achieve an effective patient access to the innovation, the product must demonstrate value to the funder, the payer, the clinicial, and the patient. We develop different types of health economic models from Early-Phase to highly complex. Demonstrate the economic value.

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    The key to unlocking market access, is the ability to look beyond the science, to understand the market dynamics that will shape the future and drive value. To gain market access in pharma and remain competitive, pharmaceutical and medical technology manufacturers must be able to demonstrate clinical and economic evidence to providers, healthcare decision-makers and payers.

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    Being a global company with an extensive geographical reach, thus far, PharmaLex can carry out these evaluations in Europe, Australia, Canada and US.

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    The PharmaLex Team