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INTEGRATED PRODUCT DEVELOPMENT

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A HOLISTIC AND STRATEGIC ASSET MANAGEMENT PARTNERSHIP

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.

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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.

Expert Teamwork

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

Scientific advice

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.

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Chemistry, Manufacturing and Controls (CMC)

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.

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Tech Transfer / Scale-up

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).

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Statistics and Data Science

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.

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Toxicology Services

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.

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Clinical Program Development

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.

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Clinical Trial Applications

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.

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Health Authority / Agency Interaction

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?

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Regulatory Operations

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.

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Quality Management Systems

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.

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GxP Services

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.

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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.

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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.

Available Resources

WEBINARS

  • Bench to Bedside: The need for an Integrated Product Strategy
  • Medical Device Risk Management for Patient and Product Safety
  • Excipient Risk Assessment as per the EU Guidance and SMARTRISK as a solution
  • Marketing a drug in France, what are the responsibilities of an exploitant?
  • Introduction to Bayesian Methodologies in CMC
  • Biotech Drug Development Challenges and Case Studies (CMC)
  • Overview of the biotech drug development pathway
  • Achieving and maintaining REG CMC Compliance
  • Regulatory Landscape for Tissue, Cell and Gene Therapy
  • Optimize your biosimilar development strategy
  • What you need to know to submit INDs in eCTD format

RELATED ARTICLES

Why collaboration and an Integrated Product Development program are key to successful drug development
Why collaboration and an Integrated Product Development program are key to successful drug development
14th June 2022
Transforming the drug development process with an integrated strategy
Transforming the drug development process with an integrated strategy
2nd June 2022
eCTD in Australia: key steps to start a successful submission
eCTD in Australia: key steps to start a successful submission
26th May 2022

MORE RESOURCES

Thought Leadership

  • IPI publication: Non-clinical safety evaluation of vaccines accelerating clinical development
  • Chemistry Today publication: Non-clinical safety evaluation of vaccines accelerating clinical development
  • Teknoscience publication: Successful marketing of medicinal cannabis
  • Successful marketing of medicinal cannabis part II
  • Non-clinical safety evaluation of vaccines part II
  • Non-clinical safety evaluation of vaccines part I
  • Can a robust QMS help you achieve customer satisfaction?
  • Product Launch
  • Learning Lessons from Nitrosamine Impurities
  • Drug Development Decisions
  • The FDA is shifting focus to both ends of the NPD spectrum
  • Improving Availability of Medicines in the EU
  • EMA simplifies the process for internal transfer of MAs

Fact Flyers

  • Strategic Regulatory Operations
  • FDA meetings and health authority interactions
  • Veeva Vault RIM Implementation
  • ATMP Quick Links and Guidelines
  • Advanced Therapies - Navigating through the Regulatory Framework
  • Regulatory Compliance - CMC Implementation
  • Biopharmaceuticals CMC
  • Health Authority Interactions
  • Chemistry, Manufacturing and Control (CMC)

Case Studies

  • System suitability control limits for assay with format
  • PharmaLex expertise secures CE certification for medical devices ‘at risk’
  • PharmaLex delivers huge sales upturn with regulatory strategy
  • MA applications to EMA and FDA in parallel
  • Dendritic cell vaccine (oncology)
  • Regulatory CMC Compliance reduced risk
  • Pre-IND Meeting
  • Type C Meeting
  • End of Phase-2 meeting
  • RIM-DMS Data Clean-up
  • Veeva Vault RIM Implementation
  • Consultancy and eCTD submission support for master files
  • Portfolio Maintenance Outsourcing – Global RA responsibility
  • Strategic outsourcing of mature product portfolio
  • Global CMC responsibility during portfolio integration
  • Post–M&A pharma infrastructure development
  • M&A early strategy
  • Lifecycle management for drug products
  • Regulatory CMC compliance reduced workload by 20-25%
  • Flexible eCTD publishing support
  • Due diligence for medicinal product documentation
  • US-UK Phase II clinical trial support
  • Preparation, submission and coordination of a CP for PUMA
  • ERA for an active substance in antiseptic lozenges

White Papers

  • Managing mature product portfolios - Key challenges and benefits
  • Pharma's growing interest in probiotics - a challenge or an opportunity?
  • The medical device regulations and their implications on device vigilance
  • New responsibilities for importers
  • Successful marketing of medicinal cannabis and cannabis-derived products - Part II
  • Successful marketing of medicinal cannabis and cannabis-derived products
  • Together Beyond COVID-19 - A Look at the Future
  • The Challenges of Achieving and Maintaining CMC Compliance
  • Analysis of EMA's Product Management Services
  • Nitrosamines - information for MAHs
  • Pre-IND meetings | The opportunity for early FDA feedback
  • Differing CMC requirements: US and EU

Webinars

  • Bench to Bedside: The need for an Integrated Product Strategy
  • Medical Device Risk Management for Patient and Product Safety
  • Excipient Risk Assessment as per the EU Guidance and SMARTRISK as a solution
  • Marketing a drug in France, what are the responsibilities of an exploitant?
  • Introduction to Bayesian Methodologies in CMC
  • Biotech Drug Development Challenges and Case Studies (CMC)
  • Overview of the biotech drug development pathway
  • Achieving and maintaining REG CMC Compliance
  • Regulatory Landscape for Tissue, Cell and Gene Therapy
  • Optimize your biosimilar development strategy
  • What you need to know to submit INDs in eCTD format

Infographics

  • INTEGRATED PRODUCT DEVELOPMENT - QUICK REFERENCE GUIDE
  • Biosimilar Development

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    8 Jun

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