Polaris

Perpend Solutions

Polaris – Driving Speed and Accuracy into the Product Submission Process

Polaris by Perpend Solutions supports life sciences companies operating in a global market with increasing regulatory complexity and evolving compliance standards.
European Medicines Agency (EMA) is implementing the standards developed by the International Organization for Standardization (ISO) for the Identification of Medicinal Products (IDMP). These standards establish harmonized definitions and formats for identifying and describing medicinal products for human use.
The implementation of ISO IDMP enables the reliable, consistent exchange of medicinal product information by creating a common “product language” across regulators, manufacturers, and other stakeholders. As part of this transition, EMA is replacing its existing data-submission formats with ISO IDMP-compliant terminology and structures.

Polaris – SAP Cloud Application by Perpend Solutions
Polaris is a cloud-based SAP application designed to consolidate structured and unstructured data across the enterprise to support electronic regulatory submissions for marketing authorization.



To prepare product information submissions, companies must gather large volumes of data from regulatory, R&D, supply chain, and other business functions. Polaris enables:
Integration, aggregation, and harmonization of enterprise data
Conversion of data into ISO IDMP standards, terminology, and formats
Preparation and management of regulatory dossiers
Adaptation to evolving global regulatory requirements through a flexible architecture
Polaris ensures that product data is submission-ready, standardized, and aligned with global regulatory frameworks.

Overview

What is Polaris?

Polaris is an SAP cloud application that consolidates product information from multiple enterprise systems, including ERP, MDG, PLM, clinical trial systems, and external data sources (e.g., Excel).

It supports:

  • Management of product information (medicinal products, medical devices, FMCG products)
  • Preparation, submission, and tracking of regulatory dossiers
  • Management of structured and unstructured data
  • Controlled vocabulary management
  • Planning, tracking, and integration of product changes
  • Embedded data quality and consistency checks
  • A flexible framework supporting current and future global data-exchange procedures

Polaris integrates seamlessly with SAP ECC and SAP S/4HANA environments and aligns with SAP’s standard approach for managing regulatory submission and product registration processes.

Key Features of Polaris by Perpend Solutions

1) Product Information Aggregation & Publication Platform

  • Enterprise-wide collaboration leveraging master data from PLM, ERP, MDG, and embedded RIM systems
  • Harmonization of data from SAP and non-SAP systems
  • Integration of controlled vocabularies
  • Automated and integrated data exchange with regulatory authorities

2) Transparency Supporting Data Quality & Reporting

  • Simple, intuitive user interface providing consolidated product data views
  • Identification and correction of inconsistencies
  • Integrated management of product versions and lifecycle extensions
  • Automated alerts for significant data changes and impact analysis

Advanced reporting and analytics capabilities

3) Built-in Extensibility

  • Flexible architecture accommodating current and future global data-exchange procedures
  • Scalable framework adaptable to life sciences and FMCG industries
  • Support for regulatory submission processes and e-commerce product information publication

Why Perpend Solutions?

Perpend Solutions combines deep regulatory expertise with SAP technology to help life sciences organizations:

  • Accelerate regulatory submission timelines
  • Improve data quality and consistency
  • Ensure ISO IDMP compliance
  • Reduce manual effort and duplication
  • Increase transparency across regulatory operations

With Polaris, Perpend Solutions empowers companies to transform regulatory complexity into a structured, efficient, and future-ready submission process.

Discover how Polaris by Perpend Solutions can streamline your product submission and regulatory compliance processes.