Freyr Solutions software

A smart, cloud-based eCTD software for creating, validating, and publishing the eCTD Submissions data.

Freyr rDMS is an end-to-end electronic Regulatory Document Management System (rDMS/eDMS) exclusively designed to enable Regulatory groups and departments within a life sciences organization to seamlessly create, capture, manage, organize, connect, deliver and archive Regulatory data and documents in a compliant, efficient and intuitive manner.

The cosmetic space has about 33,000+ cosmetic ingredients and majority of them are chemicals or botanicals. With growing scientific knowledge and sensitivity towards product safety, the industry is witnessing more mature and stringent guidelines by the regulatory authorities for cosmetic ingredients e.g., preservatives, colorants, and UV filters to ensure consumer safety. 

As ever-evolving Regulatory landscape demands all the stakeholders to be abreast with the current industry trends and market information, it becomes intrinsically challenging for Pharma companies to keep pace with time-critical regulatory requirements.

In this ever-evolving Life Sciences Regulatory arena, to comply with time-critical labeling mandates, organizations find it challenging to create, track and manage various aspects of drug labeling and its life cycle changes in real-time. Adding to that, manufacturers should make it a priority to maintain transparency of safety information across the channels, across the regions, and across the product life cycle. This creates an immense need for real-time label life cycle tracking and management tool.

Structured Product Labeling (SPL) & Structure Product Monogram (SPM) is the mandatory document markup standard for Regulatory submission of label content, product and facility information, and any subsequent changes to an existing label information in an electronic format. SPL-SPM format defines the structure and content of label information as required by the United States Food and Drug Administration (US FDA) and Health Canada. The US FDA has mandated SPL requirements for over 50 types of documents, and HC has mandated  SPM requirements for over 6 types of documents.

Beginning September 24, 2014 and going forward, all medical device manufacturers are required to meet the FDA mandated UDI compliance for their Class I, II and III devices, in phases.

Multiple products, multiple markets, combined with varied Regulatory requirements challenge Life Sciences organizations to capture and maintain wide variety of information in order to obtain Health Authority (HA) approvals. Adding to this, the data generated to maintain the product lifecycle, supply chain and constantly changing market requirements would also multiply the Regulatory information management complexities. In such scenarios, the biggest task for organizations is to accurately manage the information and documents across the product life cycle and also to track it for timely updates to the health authorities. This can be achieved in different ways, but the most effective solution is a complete Regulatory Information Management System (RIM System)