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Pharmacovigilance & Risk Management Solutions

Setting the Standard for Pharmacovigilance Excellence.

A reliable and effective pharmacovigilance program is more than a regulatory requirement—it is a cornerstone of patient trust and product success. With decades of experience developed as leaders in both the public and private sectors, ELIQUENT’s industry-recognized pharmacovigilance and risk management experts serve as trusted partners to global life science innovators.

ELIQUENT’s Pharmacovigilance and Risk Management Solutions are the industry gold-standard. Our expert team works across the entire product lifecycle to support innovators with precision and expertise – enabling you to confidently navigate global post-marketing surveillance, adverse event reporting, and risk management planning. No matter your pathway position, regulatory requirements, or therapeutic market – ELIQUENT’s integrated solutions align with your regulatory goals to unlock excellence.

INFO SHEET: Pharmacovigilance & Risk Management Solutions

Strategic & Technical Capabilities

With an approach that includes both strategic direction and hands-on support, ELIQUENT’s pharmacovigilance and risk management solutions optimize practices to ensure consistency, compliance and operational efficiency. Because there is no one-size-fits-all approach, each solution is built to support your regulatory objectives, while aligning with evolving global demands.

Global Support

Trusted guidance from our global pharmacovigilance team, experienced in navigating and ensuring compliance with international drug safety regulations. Our experts understand and adapt to the unique regulatory landscapes of different countries, ensuring global market success while maintaining the highest safety standards.

Regulatory Reporting

Leverage our technical expertise and deep institutional knowledge to meet complex pharmacovigilance regulatory reporting obligations. Our team stays abreast of the latest regulatory changes and guides you through the intricate process of compliance reporting, ensuring timely and accurate submissions.

Adverse Event Reporting

Our systematic approach to adverse event reporting ensures that all unintended occurrences are meticulously documented, analyzed for patterns and causes, and reported in accordance with regulatory requirements, enhancing the safety profile of your products.

Post-Market Surveillance

Our established network of pharmacovigilance experts support commercial product safety systems and reporting functions, providing real-time insights and responses to potential safety issues.

Signal Detection

Utilize our expert development and implementation of advanced signal detection processes, which include comprehensive reporting and effective risk communication strategies. We help you detect and analyze safety signals early, facilitating proactive measures to mitigate risks and protect patient health.

Risk Assessment & Management

Engage with our proactive risk assessment and management services to identify and evaluate potential safety risks associated with your products. We develop strategic plans to manage these risks, ensuring ongoing regulatory compliance and supporting the overall safety strategy of your products in the marketplace.

Risk Communications

Collaborate with us to strategically develop and execute risk communication plans that address emerging safety concerns effectively. Our communications strategies are designed to instill confidence among stakeholders and the market, ensuring transparent communication of risk management efforts and safety updates.

Clinical Trials Safety Oversight

Our team supports your safety monitoring processes both before and after regulatory approval, ensuring that all safety data is vigilantly collected, analyzed, and reported, paving the way for successful market entry and patient safety continuity.

QPPV

ELIQUENT’s QPPV (Qualified Person for Pharmacovigilance) solutions provide clients with the expertise and oversight needed to ensure full regulatory compliance. From monitoring and reporting to managing compliance across global markets, we ensure clients meet EU, UK, and regional pharmacovigilance requirements, while safeguarding patient safety.

Global PV Training

Tailored to your organization’s specific needs and led by our globally recognized leaders in pharmacovigilance and risk management, ELIQUENT’S bespoke pharmacovigilance training programs equip your team with the knowledge and skills needed to uphold the highest regulatory standards across diverse global markets.

SME Spotlight Shelley Gandhi

A globally recognized leader in pharmacovigilance and risk management, Shelley Gandhi brings more than three decades of experience to her role at ELIQUENT Life Sciences.

Shelley’s extensive professional background includes more than 19 years of service at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). During her tenure, Shelley served in multiple senior positions, including a role as the UK representative on the European Medicines Agency’s (EMA) EudraVigilance Expert Working Group. In this capacity, Shelley was instrumental in shaping key pharmacovigilance processes and systems across Europe.

Shelley’s firsthand knowledge of regulatory expectations and her proficiency in navigating complex safety assessments and reporting challenges are invaluable to life science innovators.

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Specialized Service Offerings

ELIQUENT provides the strategic direction and technical expertise that clients count on as they encounter complex regulatory challenges. Our team of industry-recognized professionals guide clients from the earliest phases of development through post-market support. ELIQUENT’s strategic and technical Pharmacovigilance & Risk Management Capabilities include:

Global Safety Advisory Solutions

ELIQUENT’s Global Safety Advisory Solutions are designed to support and enhance the safety of your pharmaceutical products from early clinical development through to post-market surveillance with a proactive approach to managing drug safety and regulatory challenges on a global scale.

Pharmacovigilance System Optimization

ELIQUENT specializes in designing and optimizing pharmacovigilance systems, ensuring seamless integration during mergers and acquisitions, and enhancing oversight of PV vendors. Our services are designed to streamline operations, reduce risks, and improve compliance across all facets of pharmacovigilance.

Safety Operations

ELIQUENT ensures that every level of your organization is integrated and aligned with international safety standards, providing comprehensive support tailored to your specific needs.

Inspectional Readiness

With decades of experience and a track record of success, our team of unmatched experts develop customized strategies to prepare for inspections and align with regulatory expectations.

Regulatory & Medical Writing

ELIQUENT’s Regulatory Writing Solutions ensure your safety documentation is not only compliant but also strategically aligned to support the long-term safety and efficacy of your product.

Expert Training Solutions

Our training solutions teams with the skills and tools to create pragmatic problem-solving processes and maintain adherence to evolving regulatory, compliance, and quality standards.

Market Solutions

With a robust understanding of global regulatory requirements, ELIQUENT provides tailored solutions that support pharmaceutical, biotechnology, medical device, and combination product companies navigating the complex regulatory landscape. Our team of highly qualified experts bring decades of regulatory, quality, safety, and clinical experience in the following markets specialties:

Drugs & Biological Products

ELIQUENT’s team of experts provide strategic and technical guidance on drugs and biologics from product development to regulatory review and beyond post-market requirements.

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Advanced Therapies & CGTs

Our team of regulatory and clinical experts apply their specialized skill-set to move complex therapies through the regulatory process to manufacturing and beyond.

Medical Devices & Diagnostics

Leverage our team’s extensive experience as you navigate the process of bringing new devices and diagnostics to market and manufacturing them to quality standards.

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Combination Products

Unlock the full potential of your combination product. Our team supports companies developing combination products with expert guidance throughout the product lifecycle.

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Cosmetics

ELIQUENT’s knowledge and understanding of the evolving cosmetics regulatory landscape provides clients with a trusted partner when developing and commercializing cosmetic products in compliance with regulations.

Industry Due Diligence

ELIQUENT applies vast institutional knowledge to equip investors with the information needed to ensure life science transactions account for business objectives, regulatory risks, and the industry landscape.

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Global Solutions

Expertise beyond borders. ELIQUENT’S established and growing global presence spans the regulatory process and major markets. Our premier team of global regulatory experts support markets across the U.S., Europe, and Asia.

United States

ELIQUENT is a leading Food & Drug Administration (FDA) regulatory consulting firm that provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies.
Our experts have shaped the landscape of FDA regulatory policy and strategy for decades. We bring this unrivaled knowledge and unique insight to our work with clients every day.

Europe

The ELIQUENT team applies their deep and diverse knowledge of European regulations to keep clients in lock step with evolving global standards. With decades of experience in the European market, our team understands the intricacies of the European Medicines Agency (EMA) and offers tailored solutions to ensure products meet and exceed the needs of our clients.

Asia

ELIQUENT offers regionally specialized solutions for the innovators across Asia. Our comprehensive solutions include expert guidance to innovators seeking approval in Japan, the third-largest pharmaceutical market in the world. Explore ELIQUENT’s solutions for clients in Japan’s life sciences market.

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300+ years of collective FDA experience

Over 160 INDs submitted with a 98% success rate.

Submitted over 50 applications for breakthrough therapies.

Focus Areas

ELIQUENT’s foundation is built on experts with the foremost strategic and technical skill across markets, pathways, and global regulations. ELIQUENT’s specialized solutions showcase our collective capabilities and combined expertise. Together, we create a full-service model that equips clients with a premier regulatory resource.

Market Solutions

Guided by decades of regulatory and clinical experience, our premier team of life science experts have the specialized skills to assist clients across therapeutic areas, modalities, and markets.

Market Solutions

Pathway Solutions

As former regulators and industry leaders, our understanding of the product lifecycle is unrivaled. Clients turn to our team for strategic direction and hands-on execution services that support the earliest phases of development to post-approval and beyond.

Pathway Solutions

Global Solutions

ELIQUENT’S established and growing global presence spans the regulatory process and major markets. Our premier team of global regulatory experts support markets across the U.S., Europe, and Asia.

Global Solutions

Integrated Solutions.

Full-Service Support

ELIQUENT’s unprecedented assembly of regulatory leaders, industry experts, and technical specialists collaborate seamlessly to provide a full-service engagement that delivers end-to-end support. No matter your pathway position, regulatory requirements, global market, or therapeutic area – ELIQUENT’s integrated solutions align with your regulatory goals to unlock regulatory success.

Regulatory Affairs Solutions

PV+ Post Market Surveillance

Quality & Compliance

Remediation Solutions

Talent Solutions

From the earliest phases of innovation through regulatory submissions, to post- approval support, our robust blend of technical skill and clinical expertise guide companies to approval and beyond.

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With an approach that includes both strategic direction and hands-on global support, ELIQUENT’s customized pharmacovigilance solutions empower companies to operate with confidence.

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Our team of highly specialized quality & compliance experts build customized solutions that equip companies with best-in-class strategic support, technical expertise, and project-based solutions.

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ELIQUENT’s Remediation Solutions address challenges head-on, providing the expert guidance life science innovators need to bring your operations back into compliance and securing your path forward.

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Whether you need a team of one or 100+, ELIQUENT’s talent solutions gives you the ability to rapidly scale your team to the right size, with the right level of expertise, in the right locations.

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Your resource for regulatory clarity.

IQ Central is your resource for industry insights, expert perspectives, and valuable tools. Here, you’ll find a comprehensive collection of collateral, expert resources, and thought leadership designed to support your goals and keep you informed on the latest trends and help you navigate today’s regulatory landscape.

RESOURCES

Information Sheet

Pharmacovigilance
& Risk Management Solutions

Download

Information Sheet

ELIQUENT’s Global
Regulatory Affairs Solutions

Info Sheet

THOUGHT LEADERSHIP

Quality Systems in Drug Development

Read Steven Bowen, Ph.D.’s article in the Journal of Pharmaceutical Sciences.

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Case Study: ELIQUENT Outcomes

Global regulatory strategy for immunology company to regulatory success.

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SOLUTIONS

Regulatory Writing Solutions

Explore ELIQUENT’s Regulatory & Medical Writing Solutions.

Regulatory Writing Solutions

QMSR Solutions

Explore ELIQUENT’s Quality Management System Regulation (QMSR) Solutions.

QMSR Solutions

Ready for regulatory clarity? Contact us.