For global pharmaceutical companies – IT Services for Regulatory Processes.

Regulatory Services

Mai 31, 2023

The diversity and quantity of pharmaceutical regulations that must be observed in the approval of medicinal products are immense and are subject to continuous changes. The ability to react quickly to these changes or to necessary changes originating in safety signals, efficacy data, warnings, etc. is a prerequisite to meet local and global compliance requirements.

End-to-end regulatory information management (RIM) systems orchestrate and streamline all these data and processes, enabling concerns to respond more accurately and efficiently to these changes.

We offer a wide portfolio in the field of regulatory operations to generate competitive advantages while ensuring compliance for our clients. Starting with project management, through implementation, validation, and data migration, to tailored user training, and support activities. Inconsult is your partner for regulatory services in the age of digital transformation.

Reference Project

The Regulatory Affairs department faces a significant challenge in compiling drug approval documents for different countries. They must gather numerous documents and data from various departments and storage locations, often encountering issues with data silos and data quality. Additionally, drug approvals occur through different procedures, with local and global regulations constantly changing, leading to significant impacts on the required documents and data.

By implementing the End-to-end Veeva Vault RIM system, regulatory submissions have been streamlined onto a single platform. This has eliminated data silos, improving the availability and quality of data and documents. Consequently, the Regulatory Affairs department can now respond more quickly to safety signals, new efficacy data, warnings, and other important information.

The advantages of utilizing the End-to-end regulatory information management systems, along with Regulatory DMS and Regulatory Intelligence, are evident. These systems orchestrate and streamline data and document-related processes, allowing organizations to reduce their time-to-market and gain competitive advantages.

Inconsult has made significant contributions in this regard. They provide a wide range of IT services aimed at generating competitive advantages while ensuring compliance for their clients. Their services include process visualization, user stories and requirements specification, coordination of validation and testing, creation of validation documents, migration of documents and data into Veeva Vault, integration services, as well as planning and conducting training sessions.

Our Service Portfolio

Cloud Strategy
Inconsult helps develop cloud strategies by evaluating the current and desired states, identifying gaps, and creating initiatives to close them, offering faster access to infrastructure, shorter time-to-market, and business continuity.
Process Modeling
Inconsult analyzes and streamlines your processes & systems, benchmarks to industry standards, and provides effective change management guidance to implement new technologies and processes that add actual value.
Regulatory Operations Implementation, Compliance & Validation, Migration
Inconsult has specialists for each area of RIM system implementation. From the know-how in implementing regulatory operations to ensuring compliance or migration of data or the subsequent validation of these and the system. We work hand in hand to ensure a smooth and fast implementation.
System Interfaces
The cross-system processing of data requires the use of interfaces. Inconsult has many years of experience in configuring standard interfaces as well as developing customized solutions for our clients.
Training
Due to our typically long-standing customer relationships, we can not only design tailor-made training courses and workshops including training materials but also conduct them in both German and English.
Service & Support
We offer comprehensive service and support to help simplify our customer's processes, so they can focus on their core business while our experienced team takes care of the rest.