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 foresighted 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 and compliance support and a well-planned market access approach.
A Bench to Bedside Approach
Our Integrated Product Development team delivers holistic support from discovery through to development, preparing everything for a smooth transition to product launch, including clinical and medical writing and guidance and support during critical agency interactions.
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.
Integrated Product Development is based on a highly collaborative, multidisciplinary approach. Our Integrated Product Development teams work closely with subject matter experts on a variety of topics including:
Services At A Glance
Getting the best out of Scientific Advice from Health Authorities
Having provided Scientific Advice for more than 150 clients over the last five years, PharmaLex has considerable experience in leading clients through the process, with FDA in the US, the EMA in the EU and other major Health Authorities in- and outside of the EU.
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.
Pharmaceutical batch sizes manufactured to support the NDA or ANDA license application are typically scaled up after approval.
FDA Scale-up and Post Approval Changes (SUPAC) guidance provides recommendations to product license holders on scale-up of the process and making a change to the site of manufacture or testing post NDA or ANDA approval. Scale-up activities should be managed under the Pharmaceutical Quality System (ICH Q10).
The Benefits and Best Practices of Data Analytics
The Global Statistics and Data Science (GSDS) team at PharmaLex delivers analytical support for the development of medical products from early research through pre-clinical to late phase studies, plus manufacturing and health economics.
Any chemical can be harmful to the human body (hazardous) when the dose (exposure) is sufficiently high. However, when you put the hazard data into the right context of patient exposure (dose) it informs whether patient safety is unlikely to be compromised and therefore the likelihood of regulatory acceptance. This is the foundation of toxicological risk assessment. It is a regulatory expectation that such an assessment is performed by toxicologists who possess adequate educational qualifications and experience. PharmaLex has an experienced team of toxicologists to guide you through a risk assessment.
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.
With clinical regulations continuing to evolve around the world, it is more important than ever to have the right expertise by your side. PharmaLex provides support for all aspects of Clinical Trial Authorization (CTA) and Investigational New Drug (IND) applications.
Ensuring regulatory success
Meetings with Health Authorities such as the FDA in the US, the EMA in Europe and other major regulatory bodies worldwide have shown to increase the probability of market approval and can favorably impact on development times and costs. Since Health Authorities make the final decision to approve or reject products, it is highly recommended to optimize authority communication through face-to-face and teleconference meetings all along the development pathway. But how do you get the best out of your meeting with a Health Authority?
Modern Regulatory Operations is about proactively implementing efficient information management, scalable operational excellence, and innovative digital solutions like regulatory automation.
For over 15 years, we have led the way in regulatory submissions with an evolving holistic approach that includes everything from planning to embedded quality control. Of course, all of our services are complemented by state-of-the-art digital facilitation.
The Quality Management System (QMS) is the backbone of every life sciences organization. It is the formalized system that documents procedures, processes and responsibilities for achieving regulatory and quality policies and objectives.
A well designed, tailored and implemented QMS should enable and facilitate your organization to effectively and efficiently progress through R&D, Clinical and Commercial operations. A one-size-fits-all approach is neither practical nor preferable. Instead, the QMS should be phase-appropriate. It should be fitted and adapted to the organization’s development stage – whether you’re in early clinical, late clinical or commercial – and to your business model, for example: in-house manufacture versus virtual or contract manufacture.
Ensuring your internal systems, or those of your supplier or client, meet the necessary requirements is essential before undertaking any regulatory process. It is also pertinent to follow good practice (GxP) guidelines in order to satisfy the regulators that all aspects meet their standards.
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.
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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