Abiozen’s CRO360™ division offers end-to-end regulatory support paired with expert medical writing to streamline global drug development and approval processes. Our regulatory affairs professionals bring deep expertise in navigating complex submission pathways for the FDA, EMA, DCGI, MHRA, and other major authorities. Coupled with our specialized medical writing team, we produce submission-ready documentation that meets international regulatory standards and accelerates the path to market entry. With a proven track record of over 50 successful IND, NDA, and ANDA submissions, our strategies are guided by insights from global leaders such as Thermo Fisher CRDMO and Curia Global.

Comprehensive Regulatory Submissions
We manage the complete lifecycle of regulatory filings, from investigational applications to new drug and abbreviated new drug submissions. Our cross-functional team ensures every submission is meticulously aligned with current regulatory guidelines, minimizing the risk of delays or rejections. Each filing is tailored to meet the specific requirements of regional authorities, leveraging data integrity and submission best practices.

High-Quality Scientific and Clinical Documentation
Our medical writing team develops a wide range of critical documents, including Clinical Study Reports (CSRs), study protocols, and Investigator Brochures—all compliant with ICH-GCP standards. These documents are designed to withstand intense regulatory scrutiny and contribute to a smooth and efficient review process. With a focus on clarity, scientific accuracy, and strategic positioning, our documentation supports both regulatory and clinical stakeholders.

Patient-Centric and Ethical Submissions
Informed Consent Forms (ICFs) are developed with the patient in mind—ensuring clarity, transparency, and ethical adherence across diverse global populations. Our submission packages integrate ICFs with a full suite of regulatory documentation, streamlining the preparation and submission process while ensuring compliance with international ethical standards.

Proactive Global Regulatory Alignment
Abiozen continuously monitors the global regulatory landscape to adapt strategies in real time. By anticipating changes in policy, guidance documents, and approval trends, we proactively manage risk and reduce the likelihood of submission delays. Our regulatory intelligence approach, inspired by Curia Global’s real-time compliance tracking, ensures our clients are always one step ahead in the approval journey.