At Abiozen, our commitment to product safety and regulatory excellence continues long after clinical trials conclude. Through a robust post-market surveillance framework and global regulatory submission capabilities, we help our clients meet evolving compliance obligations, monitor real-world product performance, and drive commercial expansion. Our lifecycle management services are designed to maximize therapeutic value, support patient safety, and enable sustained market presence across geographies.

Safety Monitoring and Pharmacovigilance
Our global pharmacovigilance infrastructure ensures continuous monitoring of drug safety in the post-approval phase. Equipped with a centralized safety database and real-time adverse event reporting systems, we track, analyze, and report safety signals in accordance with international regulations. This system supports compliance with FDA, EMA, MHRA, DCGI, and other global health authorities, reducing risk and safeguarding patient populations. Inspired by Curia Global’s safety oversight model, we ensure transparency, responsiveness, and regulatory adherence at every stage of the product lifecycle.

Regulatory Filings and Market Authorization
We manage post-approval regulatory submissions for new markets, new indications, and label updates, aligning documentation with the specific requirements of each jurisdiction. Our experienced regulatory affairs team handles variations, renewals, and supplemental filings with precision—ensuring a streamlined path to expanded market access. Whether pursuing accelerated pathways or standard review routes, we help sponsors maintain compliance while capitalizing on growth opportunities.

Market Expansion and Lifecycle Extensions
Abiozen supports commercial strategy through formulation enhancements, geographic rollouts, and indication extensions. We work closely with marketing and medical teams to identify and execute opportunities that extend product lifespans and drive profitability. From reformulation for new patient populations to entry into emerging markets, our approach integrates regulatory foresight with strategic execution—ensuring lifecycle success aligned with business objectives.