Case Study: Global Clarity for Complex Substances - How GSRS is Powering Regulatory Science

Background

Every drug, vaccine, and therapeutic product begins with a substance. But globally, regulatory bodies have long struggled to align on what a substance is. From salts and mixtures to biologics and novel adjuvants, inconsistent definitions led to safety blind spots, delays in drug approvals, and barriers to international harmonization.

Problem

Biomedical data complexity doesn't stop at patient-level information. One of the most persistent issues in pharmaceutical development and public health is the lack of consistency in substance identification. Across countries, agencies, and even internal systems, there is no unified approach to defining what constitutes a substance. This inconsistency creates downstream issues in product labeling, pharmacovigilance, safety surveillance, and regulatory review.

A globally accepted system was needed—one that could assign unique, persistent identifiers, model complex substance relationships, and align with international standards like ISO IDMP.

Nextonic's Solution

Nextonic Solutions supported the implementation of the Global Substance Registration System (GSRS), an open-source, standards-compliant informatics platform that defines and manages structured substance records.

We contributed to:

• Modeling diverse substance types—from small molecules to nucleic acids

• Linking GSRS records to global identifiers like UNII, RxNorm, and WHO-INN

• Supporting ISO IDMP and SPL compliance for international alignment

• Enabling tracking of substance relationships (salts, derivatives, mixtures)

Results and Outcomes

GSRS is now a cornerstone for regulatory consistency and pharmacovigilance:

• Regulatory agencies use it to support structured product labeling and accurate submission reviews.

• Pharmacovigilance teams rely on GSRS to detect ingredient-based safety signals across products.

• Emergency responders leveraged it to track vaccine ingredients and novel adjuvants during the COVID-19 pandemic.

• Global harmonization efforts are aligning substance definitions across borders thanks to GSRS’s shared infrastructure.

Strategic Impact

GSRS improves the integrity, traceability, and global alignment of pharmaceutical substances—directly enhancing drug safety, regulatory compliance, and emergency responsiveness. It lays the foundation for international regulatory convergence, reduces risk in supply chains, and accelerates safe access to critical therapies worldwide.