Services

We are dedicated to guiding your firm through its Research & Development journey.

To learn more about how Irving can provide value to you, click the options below:

Strategic Planning

At Irving, we believe that developing a robust portfolio strategy is crucial to your success in the competitive biopharmaceutical landscape. Leveraging our in-depth industry knowledge and analytical expertise, we offer a comprehensive portfolio strategy service designed to fuel your growth and maximize returns on your R&D investments.

Every innovative therapy in your pipeline represents an opportunity for breakthroughs in patient care, but not all are created equal in terms of potential success, market impact, and profitability. That's why we approach portfolio strategy with a keen eye for identifying and prioritizing the most promising assets. Our seasoned professionals delve into detailed analyses of your products - comparing their strengths, risks, and market potentials.

Beyond this, we offer a 360-degree view of the competitive landscape, helping you understand where your products stand among competitors. We assess market trends, patent cliffs, regulatory changes, and emerging technologies that could affect your portfolio's performance. By understanding the external environment, we help you anticipate challenges and seize opportunities.

With these insights, we assist you in aligning your portfolio with your corporate strategy, balancing risk and reward across therapeutic areas, development stages, and markets. We advise you on when to invest, divest, or partner, ensuring your resources are optimally allocated to generate the highest returns.

Partner with Irving for your strategic planning needs, and let's chart a clear, actionable path to success in the dynamic world of biopharmaceuticals. Together, we will drive your growth, maximize your profitability, and bring life-changing therapies to the patients who need them most.

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Drug Discovery and Development

At Irving, we believe that every groundbreaking therapy begins with the spark of discovery and is nurtured through meticulous development. Our "Drug Discovery and Development" service is designed to transform your innovative ideas into tangible healthcare solutions that improve patients' lives worldwide.

Navigating the intricate maze of drug discovery and development can be challenging and time-consuming. Our team of seasoned scientists and industry professionals is here to guide you at every step of this journey, from initial target identification and validation, through hit generation and optimization, to preclinical testing.

During the discovery phase, we support your efforts in identifying and validating potential drug targets, using a combination of cutting-edge technology and robust bioinformatics tools. We assist in high-throughput screening and hit identification, leveraging our expertise to streamline the selection of potential therapeutic compounds.

In the hit-to-lead and lead optimization phases, we help refine these compounds for improved potency, selectivity, and safety, using predictive modeling and extensive structure-activity relationship (SAR) studies. Our team provides insights into molecular modifications that can improve drug-like properties and increase the chances of clinical success.

As you transition into preclinical development, we help design and interpret key ADMET studies to evaluate your drug candidate's absorption, distribution, metabolism, excretion, and toxicity. Our risk-based approach ensures a thorough evaluation of potential safety issues, effectively managing risks and expediting your transition to clinical trials.

Partner with Irving, and you'll not only benefit from our scientific expertise but also our deep understanding of the regulatory landscape. We ensure that your drug discovery and development processes meet the highest scientific and regulatory standards.

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Clinical Trial Management

At Irving, we understand that clinical trials are the pivotal gateway through which groundbreaking therapies reach the patients who need them most. They are also complex, resource-intensive endeavors that can significantly impact your drug development timeline and budget. That's why we offer comprehensive clinical trial management services designed to optimize your trials, ensuring they run smoothly, generate high-quality data, and stay on schedule and within budget.

Our team of experienced clinical trial managers and coordinators, biostatisticians, and regulatory experts is dedicated to making your clinical trials as efficient and effective as possible. We start by assisting you in the critical planning stages, developing a robust protocol that addresses your scientific objectives while meeting regulatory requirements. We can also advise on site selection, leveraging our extensive network and deep understanding of North American clinical trial landscapes to identify the most suitable locations for your study.

Patient recruitment is often a significant bottleneck in clinical trials. At Irving, our contractors use innovative recruitment and retention strategies to ensure you have the right patients for your study and keep them engaged until the trial's conclusion. Our goal is to minimize delays and disruptions caused by patient recruitment and retention challenges.

Once your trial is underway, we provide ongoing management support. This includes monitoring trial progress, ensuring protocol adherence, managing data collection and verification, and swiftly addressing any issues that may arise. Our expert biostatisticians work alongside trial managers to ensure rigorous data analysis and interpretation.

Our team also excels in the critical areas of safety monitoring and regulatory compliance. We'll establish a robust framework for adverse event reporting and safety monitoring, keeping patient welfare at the forefront. Meanwhile, our regulatory experts will ensure that your trial maintains strict adherence to evolving regulations and guidelines, safeguarding your path to market approval.

Choosing Irving for your Clinical Trial Management needs is choosing a partner dedicated to your success. Let us navigate the complexities of clinical trials together, ensuring that your innovative therapies get one step closer to the patients waiting for them.

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Regulatory Affairs

Navigating the labyrinth of regulatory requirements is a critical and challenging aspect of drug development. At Irving, our regulatory services aim to demystify this process, ensuring your innovative therapies comply with the latest regulatory standards and efficiently reach the patients who need them most.

Our team of regulatory affairs specialists is well-versed in the evolving landscape of North American biopharmaceutical regulations, guidelines, and procedures. They bring together extensive experience from diverse backgrounds, including previous roles in regulatory agencies, to provide you with informed and current insights.

In the initial stages of drug development, we help establish a strategic regulatory plan that aligns with your overall development strategy. We work with you to understand the specific regulatory requirements for your product and target markets, ensuring you are well-equipped to meet these requirements throughout your development journey.

As your product advances through clinical trials, we assist with the preparation, submission, and follow-up of regulatory filings, including New Drug Submission (NDS) applications and Clinical Trial Applications (CTAs). Our meticulous preparation and careful coordination with regulatory agencies aim to avoid unnecessary delays and ensure a smooth review process.

Post-approval, we provide ongoing regulatory support to help maintain compliance in a dynamic regulatory environment. From label updates and post-marketing surveillance to managing regulatory aspects of product changes, we ensure your product stays compliant, protecting your investment and the trust of your patients.

Choose Irving as your partner in regulatory affairs. Together, we can turn the challenge of regulatory compliance into a strategic advantage, accelerating the journey of your innovative therapies from the lab to the market, and ultimately to the patients awaiting these life-changing solutions.

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Quality Assurance and Compliance

At Irving, we recognize that maintaining uncompromising quality standards and staying in compliance with regulatory guidelines are crucial not just for market approval but for the trust of patients and stakeholders. This is why we offer comprehensive Quality Assurance (QA) services to help you embed quality into every layer of your operation and remain compliant in a complex regulatory landscape.

Our team of quality assurance specialists and compliance experts brings together vast experience and deep understanding of global pharmaceutical quality standards and regulations. They are committed to ensuring that your products are not only safe and effective but meet the highest quality benchmarks, setting you apart in the market.

Starting with the design and implementation of Quality Management Systems (QMS), we help you build a robust framework for consistent delivery of products that meet regulatory requirements and patient needs. Our QMS design considers all aspects of your operation - from drug discovery and development, through manufacturing, to post-marketing surveillance - ensuring quality is not an afterthought, but a guiding principle.

Our services also extend to quality control, where we help establish efficient testing strategies and protocols to monitor the quality of your products. Our team can also provide training and support in implementing Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP), forming a solid foundation for your team to deliver high-quality work.

In the realm of compliance, our specialists stay ahead of the curve, keeping track of evolving regulations, guidelines, and industry best practices. We translate these into actionable insights for you, providing regular updates and recommendations to ensure your processes, procedures, and products remain in compliance.

We also offer support during regulatory inspections, helping you prepare thoroughly and handle the process confidently. Our post-inspection services include helping address any issues identified, devising corrective and preventive action plans, and assisting in follow-up communications with regulatory agencies.

Choose Irving as your partner in quality assurance and compliance. We will work hand-in-hand with your team to uphold the highest quality standards and navigate the complexities of compliance, instilling confidence in your stakeholders and bringing your life-changing therapies to patients more efficiently.

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Market Access and Pricing

At Irving, we understand that reaching patients with your innovative therapies involves more than just successful development and regulatory approval; it requires effective market access and pricing strategies. With our "Market Access and Pricing" services, we are committed to helping you overcome these challenges, ensuring your products reach the patients who need them most, at a price that reflects their value.

Our team of market access and pricing specialists brings a wealth of experience and a deep understanding of North American healthcare systems, payer landscapes, and pricing regulations. We work closely with you to design and implement strategies that align with your product’s unique characteristics, target markets, and your overall business objectives.

For market access, we start by thoroughly assessing the landscape, identifying potential barriers, and formulating strategies to overcome them. We evaluate the unmet needs, treatment algorithms, competitive environment, and payer expectations in your target markets. By identifying key decision-makers and influencers, from healthcare providers to insurance companies and patient advocacy groups, we ensure that your value proposition reaches the right stakeholders.

In parallel, we develop a pricing strategy that captures the value of your therapy while considering the complexities of different pricing and reimbursement systems around the world. We analyze factors such as clinical efficacy, safety, cost-effectiveness, and the socio-economic impact of your product. Our goal is to set a price that is not only acceptable to payers and patients but also maximizes your return on investment.

At Irving, we don’t stop at strategy formulation. We are with you throughout the implementation, negotiation, and post-launch phases. Whether it’s preparing compelling dossiers for health technology assessment (HTA) submissions, negotiating with payers, or monitoring post-launch market dynamics and adjusting strategies accordingly, we offer end-to-end support in market access and pricing.

Choose Irving as your partner in market access and pricing. Together, we will ensure your innovative therapies are accessible and affordable to the patients who need them, while securing your market position and profitability in a competitive and regulated environment.

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