Regulatory Software

For years, Regulatory publishing was done by manual tasks. Publishers used to work for hours formatting documents, generating Agency-compliant PDFs, performing quality checks, compiling documents for submissions, and troubleshooting issues related to submissions.

Moreover, pharmaceutical companies are under immense pressure to submit error-free documents within stringent timelines. The inability to meet the timelines delay the product launch.

The post-pandemic world is realizing that the intersection of technology and a traditional way of doing business already exists with us. The highly competitive nature of our business only exemplifies the need of incorporating innovative technologies to augment and support customers in the ever-evolving Regulatory landscape. Trends show that the global automation market, especially in the life sciences industry, is poised to grow close to $2.5 bn by 2025 with a CAGR of approximately 7.5%.

As we all know, each country has its own set of cosmetic regulations that manufacturers must adhere to. Many countries have banned several ingredients, while some substances are restricted to a maximum concentration, which makes it difficult for the product manufacturers to market in different countries. During the product formulation, manufacturers must be sure that the substances used in the product formulation are permitted in the targeted country.

Structured Product Labeling (SPL) and Structure Product Monograph (SPM) are the mandatory document mark-up standards for the submission of label content, product and facility information and any subsequent changes to the existing label information in an electronic format. SPL format defines the structure and content of label information as per the United States Food and Drug Administration (US FDA), whereas SPM is for Health Canada (HC).