Integrated Product Development
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.
PharmaLex has long-standing and extensive experience of interacting with the scientific committees and working parties of the EMA (e.g. CHMP, PRAC, COMP, PDCO, CAT) and with national Health Authorities. We frequently support our clients in Scientific Advice procedures at a national or central level, and in numerous health authority interactions throughout a product’s lifecycle (e.g. requests for PRIME eligibility, Orphan Medicinal Product designations, Pediatric Investigational Plans, Marketing Authorization Applications).More Info
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 Trials Adverse Event Processing
Clinical trials play a crucial part in any drug development life cycle where it is key to gain information on a product’s safety profile. The PharmaLex international team of clinical safety experts, with large expierence in the management of clinical safety activities, effectively supports sponsors with Pharmacovigilance activities during clinical trial development programmes. PharmaLex designs …More Info
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.More Info
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.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
Health economics and outcomes research (HEOR)
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.More Info
Market Access Strategy
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.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
Regulatory Writing / Scientific and Technical Writing
PharmaLex offers scientific, regulatory and technical writing, supporting clients in the development of medicinal products.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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