Regulatory Compliance, Drug Safety and Pharmacovigilance

Strategies to reduce downtime, protect revenue, and maintain trust

In an evolving landscape, maintaining licenses, ensuring compliance with regulations and GxP requirements, and meeting post-approval drug safety and pharmacovigilance requirements can pose significant challenges. Failure to address these can result in severe consequences, including legal repercussions, reputational damage – but most importantly, disruption of the supply chain to patients.

With a team of industry experts and a global footprint, we have a proven track record of guiding companies of all sizes through the complexities of regulatory compliance and strengthening pharmacovigilance frameworks. Partner with us to safeguard your business, mitigate risks, and unlock your full potential for growth.

Our comprehensive suite of services includes:

Post-approval submissions and lifecycle maintenance

We provide comprehensive support in areas such as labeling updates and variations, allowing companies to free up their internal teams to focus on strategic activities while ensuring compliance. With our expertise companies can navigate the regulatory landscape effectively and maximize the value of their approved drugs throughout their lifecycle.

Regulatory advice

Focus on product approvals and explore potential expansion into new markets with comprehensive regulatory strategies that optimize the utilization of your approved marketing application, enabling you to penetrate multiple markets. This approach enhances ROI and your chances of success in each market.

Strategic compliance consulting

Strategic GxP advisory

Whether it’s nimbly responding to an issue or building proactive compliance strategies, our goal is to help you confidently navigate every aspect of risk mitigation, and crisis and compliance management. We do this by tailoring solutions that make sense for your situation, your supply chain, and ultimately, the patients you serve.

Auditing

Identify and resolve compliance challenges with our detail-oriented auditing services. Our auditors conduct thorough GxP audits, including mock pre-approval inspections (PAIs), verification audits, and effectiveness checks. By proactively identifying areas of improvement, we help you mitigate risks and maintain regulatory compliance.

Our team of experts offer guidance on Good Distribution Practice (GDP), Good Manufacturing Process (GMP), Good Clinical Practice (GCP) Quality Management Systems (QMS), and effective management control.

Data integrity

Ensure data integrity and build confidence in the quality of your data. Achieve data integrity through comprehensive audits, expert analysis, targeted training and streamlined procedure implementation – as well as staff interviews, internal investigations, and fraud evaluation.

Inspection support

Minimize the risk of compliance-related rejections, and ensure a smooth regulatory inspection process. Our comprehensive range of services to prepare you for your PAI include mock interviews, readiness assessments and application conformance reviews. With front/backroom support and follow up assistance, our focus is supporting you to achieve successful outcomes.

Technical writing

Accurate and comprehensive SOPs, regulatory agency correspondence, audit responses, strategic technical reports, and annual product reviews can save time and minimize the risk of compliance issues. Meet all the related regulatory requirements with documentation that precise, thorough and aligned with industry standards. 

Consent decrees and warning letters

Navigate consent decrees and warning letters with our strategic and operational compliance support. When faced with unexpected regulatory crises, we provide swift, well-balanced, and comprehensive responses to address the situation effectively. Starting with root cause identification, and delivering thorough remediation planning, implementation and execution, we help you overcome regulatory challenges and restore compliance.

Pharmacovigilance and safety

Risk evaluation and mitigation: Develop a fully compliant strategy to manage known or potential serious risk(s) associated with a medicine. Allows patients continued access to certain medicines for which there are safety concerns that can be safely managed through appropriate use. May be prepared in conjunction with European RMP.

Product Safety Update Report (PSUR): Write, compile, publish and submit PSURs, providing process efficiency with quality standards.

Development Safety Update Report (DSUR): Prepare high-quality DSURs in compliance with ICH E2F using data checklists, templates, and quality control procedures specifically tailored to DSUR production.

Integrated safety: Design, develop, and deliver end-to-end safety services to support global pharmacovigilance systems and programs. Includes pharmacovigilance system development, safety management strategy, operational processing — case processing, aggregate reporting, EU QPPV, literature searches, information call center, post-authorization safety studies, and more. Based on our global footprint, we have the capacity to rapidly ramp-up or ramp-down to support changes in operational requirements globally.

The team you can count on

With more than 40 years of experience guiding companies through complex GxP challenges, we understand not only how to do it, but the importance of reducing downtime, protecting revenue, and maintaining trust with regulators.

Whether it’s nimbly responding to an issue or building proactive compliance strategies, our goal is to help you confidently navigate every aspect of risk mitigation, and crisis and compliance management. We do this by tailoring solutions that make sense for your situation, your supply chain, and ultimately, the patients you serve.