Your trusted partners for regulatory affairs in Life Science

EXTEDO

EXTEDO is your trusted bridge between industry and agency. With EXTEDOpulse, we provide a comprehensive end-to-end Regulatory Information Management System (RIMS) that increases the efficiency of regulatory processes while guaranteeing compliance. Additional services (publishing, submission, etc.) complete our offer. 

Today, EXTEDO enables more than 35 regulatory authorities and over 1000 maintained customers across 65 countries to navigate the regulatory environment securely. Our clients range from small CROs to large multinational pharmaceutical organizations.

Our mission of Effortless Compliance™ ensures that organizations can spend more time doing the things they want to do rather than the things they have to do.

www.extedo.com

Epista Life Science

Epista Life Science's professional team operates at the confluence of corporate objectives and regulatory mandates. Leading the way in innovating methodologies, we support our customers in discovering, choosing, integrating, and sustaining software solutions. This enables them to strike a balance between risk management and operational efficiency to enhance their overall performance.

Since 2009, Epista has expanded its team to over 100 colleagues in Denmark, Sweden, and Germany. Our presence extends throughout Europe, reflecting our commitment to the enhancement of compliance and business practices. By transforming compliance challenges into business prospects, we believe we can significantly amplify the contributions of the Life Science sector to society.

www.epista.com

How EXTEDO and Epista Life Science work together

Configuration
1

Configuration 

The Configuration phase involves EXTEDO conducting workshops to define software settings while Epista moderates homework sessions for thorough analysis. Additionally, Epista facilitates, supports, and, when necessary, challenges configuration decisions to ensure optimal outcomes for our clients. 

Validation
2

Validation

In the Validation phase, EXTEDO supplies validation documentation, while Epista offers validation support to ensure regulatory compliance. Furthermore, Epista establishes a cloud qualification framework, qualifies vendors, and creates comprehensive validation documents.

Migration
3

Migration

In the Migration phase, EXTEDO supplies the migration tool, while Epista provides essential migration support. This phase involves assessing data/document sources, defining a migration strategy, preparing sources, creating migration documentation, and executing the migration process.

Business Support
4

Business Support

In the Business Support phase, EXTEDO and Epista together conduct impact assessments, make necessary updates, and create new processes to ensure alignment with changes, fostering successful adaptation and growth.

Training
5

Training

In the Training phase, EXTEDO focuses on training trainers, equipping them to effectively educate others. Epista takes the lead in training end users, including the creation of training materials, ensuring comprehensive and efficient knowledge transfer.

Get in touch with us to benefit from the double power of EXTEDO and Epista!

EXTEDO and Epista Life Science constantly provide expert support, share best practices, and offer resources to help our customers make well-informed choices that are in line with their goals. Our joint mission is to facilitate configuration decisions, guiding our clients through the whole process. If there are alternatives or concerns that need to be addressed, we're here to ensure that the final configuration serves the client's interests to the fullest. 


A long-standing partnership based on trust allows us to work together effectively at every stage of the respective project. In doing so, we support each other in a variety of ways - depending on how the customer's concerns can best be supported - and thus, together, create the best result even for demanding requirements.

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