Ensuring Compliance and Patient Safety

In the ever-evolving landscape of life sciences and healthcare, regulatory intelligence (RI) and pharmacovigilance (PV) play critical roles. Companies face multifaceted challenges that span across regulatory compliance, safety monitoring, and strategic decision-making. This is where experts like Celegence and Soterius come into play to bridge the gap between RI and PV.

Celegence offers a team of regulatory experts who understand the nuances of global regulations. They provide real-time updates on changes in guidelines, laws, and submission requirements, and collaborate with clients to develop regulatory strategies aligned with business goals. Their insights help optimize product development, market access, and regulatory labeling. By streamlining regulatory processes, Celegence ensures timely submissions and compliance.

Soterius provides end-to-end PV services, including case processing, signal detection, and aggregate reporting.Their team of PV experts ensures timely and accurate safety data collection. High-quality safety narratives and periodic safety reports (PSURs) are crucial for PV, and Soterius’ medical writers excel in creating these essential documents. Soterius leverages technology platforms for efficient data analysis, visualization, and reporting which enhance PV efficiency and compliance.

“With a combination of Celegence’s local regulatory insight, strategy, and intelligence and Soterius’ capabilities, we can leverage our extensive industry knowledge and expertise to offer technologies and services that deliver greater efficiencies for regulatory, safety and medical affairs departments.” 

– Sonia Veluchamy, Chief Executive Officer of Celegence

Celegence’s RI team ensures that organizations stay informed about regulatory changes. Soterius’ PV team monitors safety data and identifies adverse events promptly. Celegence’s regulatory insight combined with Soterius’ expertise in drug safety provide global, comprehensive coverage. Together, they bridge the gap between regional nuances and global requirements.

Regulatory intelligence and pharmacovigilance are interconnected. Companies need experts who can navigate both domains seamlessly. Celegence and Soterius bring complementary strengths to the table, ensuring safer medicines, regulatory compliance, and informed decision-making. As the life sciences industry evolves, this collaboration becomes even more critical.

Celegence supports life sciences customers in the areas of regulatory intelligence, RIMS, publishing, labeling, medical writing, and compliance with new regulations for different product portfolios. Celegence’s depth of experience and extensive delivery capability allows regulatory affairs teams to operate more efficiently, reduce cost, and improve compliance.

For more information, contact us online now or follow us on LinkedIn and Twitter.

Soterius is a trusted name in the life sciences industry for providing integrated outsourced drug safety and pharmacovigilance, medical affairs, and medical writing services with a customer base spanning Top 10 pharmaceutical companies, biopharmaceutical companies, global cosmetics conglomerates and generic drug manufacturers.

For more information, visit www.soterius.com or follow Soterius on LinkedIn and Twitter.

Explore how Celegence can revolutionize your PV writing by contacting us at info@celegence.com or visit us online.