ELIQUENT Life Sciences, a global regulatory consulting firm, is pleased to announce the addition of Shelley Gandhi, a renowned pharmacovigilance (PV) expert, to its team. This strategic hire strengthens ELIQUENT’s leadership in regulatory and quality services and underscores the firm’s commitment to providing integrated solutions that optimize compliance, manage risk, and expedite time-to-market for clients.
ELIQUENT Life Sciences has announced the appointment of Shelley Gandhi, a renowned pharmacovigilance (PV) expert, to expand its global PV and risk management offerings. With over 30 years of experience in PV and risk management, Shelley’s expertise will strengthen ELIQUENT’s ability to deliver integrated solutions that ensure compliance, manage risk, and accelerate time-to-market for clients.
Global PV Expertise
Shelley Gandhi brings more than 19 years of experience from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), where she played a key role in regulatory processes related to drug safety and monitoring licensed medicinal products. Notably, she was the UK representative on the European Medicines Agency’s (EMA) EudraVigilance Expert Working Group, contributing to the development of systems for managing adverse reactions to medicines.
In addition to her time at MHRA, Shelley has spent over 12 years advising biotech clients on building and managing risk management systems. Her expertise spans a wide range of therapeutic areas, from early clinical development to market readiness.
At ELIQUENT, Shelley will work closely with clients to ensure they meet global safety standards and proactively address potential regulatory challenges. Her deep knowledge of drug safety protocols enhances ELIQUENT’s expanded PV and Risk Management Solutions, helping clients navigate complex regulatory environments.
ELIQUENT’s Expanded PV and Risk Management Solutions
ELIQUENT’s comprehensive PV services are designed to ensure consistency, compliance, and operational efficiency across global markets. The firm’s team of industry-recognized PV experts provides tailored solutions that support regulatory objectives while meeting the evolving demands of the global marketplace. Key offerings include:
- Global Support: Guidance on navigating complex PV regulations worldwide.
- Adverse Event Reporting: Systematic identification and strategic analysis of adverse events.
- Regulatory Reporting: Expertise in meeting complex reporting obligations.
- Signal Detection: Advanced processes for detecting and communicating risks.
- Risk Assessment & Management: Proactive planning to identify and manage potential risks.
- Post-Marketing Surveillance: Ongoing support for commercial product safety.
- Risk Communications: Developing strategies to address emerging safety concerns.
- Clinical Trials Safety Oversight: Monitoring safety before and after regulatory approval.
- Qualified Person for Pharmacovigilance (QPPV): Solutions to meet EU, UK, and regional PV requirements.
- Global PV Training: Customized training to maintain the highest regulatory standards.
Integrated Full-Service Solutions
ELIQUENT offers a comprehensive platform of integrated solutions throughout the product lifecycle, guiding companies through regulatory submissions, post-approval support, and beyond. The firm’s team of regulatory leaders, technical experts, and compliance specialists work together to deliver tailored solutions in the following areas:
- Regulatory Affairs Solutions: Comprehensive support from early innovation through regulatory submissions and approval.
- Quality & Compliance Solutions: Best-in-class support and expertise in regulatory compliance and quality assurance.
- Remediation Solutions: Expert guidance for navigating regulatory remediation.
- Talent Solutions: Scalable teams with the right expertise, tailored to client needs.
About ELIQUENT Life Sciences
ELIQUENT Life Sciences is the result of the merger of six global regulatory consultancies: Validant, Greenleaf Health, DataRevive, Oriel Stat-a-Matrix, RApport Global, and IDEC. The company provides cross-functional solutions to pharmaceutical, biotechnology, and medical device companies, supporting innovators across all therapeutic areas, phase-based pathways, and global markets. ELIQUENT is backed by GHO Capital, a European healthcare investment specialist.
