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Compass® BIO

Where CMC, quality, and risk data converge for regulatory compliance.

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The SaaS Solution for Biopharma Success

Manually turning raw scientific data from Chemistry, Manufacturing, and Controls (CMC) processes into technical reports and regulatory documents isn’t just time-consuming—it opens you up to risk at every data touch. The lack of traceability and consistency across thousands of documents and millions of data points exacerbates the problem, putting your pharma product’s compliance on the line every day.

Take control of your data with Compass BIO, a Structured Content and Data Management solution for Biopharma and CDMO organizations. By enabling Quality by Design (QbD), Compass BIO transforms complex development processes into streamlined traceable workflows, ensuring regulatory compliance when it matters most.

Accelerate

Move faster from lab to market launch. Compass BIO eliminates the bottlenecks in your data pipeline and provides guided workflows that dramatically shorten the time from TPP through Tech Transfer.

Organize

Bring order to your raw scientific data. Compass BIO is a single unified system that standardizes massive amounts of data from sponsors, CDMOs, and suppliers, giving critical context for lifecycle management and regulatory compliance.

Optimize

Drive quality and reduce risk. Embed Quality by Design (QbD) effortlessly to navigate, organize, aggregate, and generate data tables, narratives, and formal reports. Compass BIO makes it easy to manage complex data relationships and projects for both large and small molecule products.

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Purpose-Built for CMC Management

From early development to submission, Compass BIO reduces the time, effort, and resources needed to create, verify, release, and update your CMC reports.

Strengthen Your Data Integrity
Get Submission-Ready, Instantly
Build Your “Single Source of Truth”
Standardize Your Data
Conquer Regulatory Compliance
Cut Development Time & Costs

Strengthen Your Data Integrity

Minimize errors, redundancies, and discrepancies to enhance the reliability and accuracy of information. Compass BIO’s seamless connectivity with data sources detects data quality issues, and allows for real-time traceability to mitigate risk in regulatory submissions.

Get Submission-Ready, Instantly

Automatically generate highly structured, reusable data items and comprehensive reports for Module 3 of the Common Technical Document (CTD). Compass BIO dynamically links data items to ensure everything is present and accounted for when it’s time to submit your dossier.

Build Your “Single Source of Truth”

Easily manage complex data relationships and projects for both large and small molecule products. Compass BIO’s unified repository presents a single set of data tables and reports throughout the entire process.

Standardize Your Data

Ensure uniformity in formatting, terminology, and content across all CMC documents with real-time guided workflows that align with company SOPs and policies. Compass BIO’s consistency makes it easier for regulatory agencies to review and assess submissions.

Conquer Regulatory Compliance

Submit your dossier with confidence about your compliance with regulatory requirements. Compass BIO maintains comprehensive documentation and audit trails to support regulatory submissions, inspections, and compliance with GXP guidelines and others.

Cut Development Time & Costs

Automate repetitive tasks, streamline data collection and organization, and accelerate document preparation with pre-built templates and predefined fields. Compass BIO helps the leading names in Biopharma realize substantial gains in ROI annually.

See how Compass BIO puts your team on the path to a simpler submission.

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Compass BIO:

The Foundation for Pharma Efficiency

With three modules centered around our trusted Repository, Compass BIO is built from the ground up to reduce manual effort, eliminate regulatory delays, and support compliance.

Repository

The foundation of Compass BIO. The Repository defines data items and relationships to support working projects, giving you rigorous control of reusable trusted data. Repository is a built-in core functionality of Compass BIO.

Risk Module

Our comprehensive data model offers tremendous flexibility to support all types of risk data and relationships for the many use cases in pharma. Risk Module is a built-in core functionality of Compass BIO.

Publisher Module

The Publisher Module engine supports the effortless, automatic generation of external documents based on work done in Compass BIO. Publisher Module is available as an optional add-on to Compass BIO.

Connector Module

The Connector Module engine supports API and other connections for automatic two-way data transfer, reducing data touches by eliminating the need for manual import and export. Connector Module is available as an optional add-on to Compass BIO.

Modular Applications to Scale Up Data Management and Reporting

Compass BIO organizes structured analytical and process data into dynamic, reusable e-Reporting templates for biologics and small molecules. Use these applications individually, or as a comprehensive suite to fully automate CMC report generation for your organization.

Compass BIO makes it easier to get started with a single module, with additional modules when you are ready to use.

Process Data Suite

Easily create and manage data while mitigating risks at every step. Compass BIO’s Process Data Suite ensures data integrity and chain of evidence through the highly structured data model of Compass BIO, workflow actions, access controls, and comprehensive audit logs. It dramatically reduces the time required to generate reports for internal consumption and formal submissions.

Recipe/ Process

Criticality Analysis

Technology Transfer

Critical Assets Risk Assessment (CARA)/eFMEA

Hazard Analysis and Critical Control Points (HACCP)

Recipe/ Process

Criticality Analysis

Technology Transfer

Critical Assets Risk Assessment (CARA)/eFMEA

Hazard Analysis and Critical Control Points (HACCP)

Analytical Data Suite

The Analytical Data Suite ensures data integrity with approved, reusable data from the Compass BIO Repository. This functionality streamlines report generation, management, and publication, automatically generating formal reports for publishing to external formats and systems. The suite provides a chain of evidence with comprehensive workflow, access control, and detailed audit logs of all user actions.

Target Product Profile (TPP)

Quality Target Product Profile (QTTP)

Specifications (SPEC)

Drug Stability

Batch Analysis

Justifications of Specifications (JoS)

Core Features

With quick implementation and robust customization, Compass BIO fits effortlessly into your team’s workflows to streamline your path to market.

Core Features Graphic
Core Features Graphic for Mobile

Success With Compass BIO

With Compass BIO, Biopharma teams can accelerate every stage of development. See their successes for yourself.

Success Stories

“We have tamed the beast of Criticality Analysis with Compass BIO. Our LM API teams consider it a core application.”

Senior Scientific Director
Strategic Science and Innovation

Tailored for the Entire Biopharma Team

Compass BIO is purpose-built by a team of developers, engineers, and industry-focused experts who have been providing product development and technical SaaS solutions for more than 25 years to the life science industry.

See how Compass BIO supports the full development team in critical CMC areas.

Executives
IT/Digital Transformation Leaders
Technical Writers and Scientists
Regulatory and Quality Leaders
CMC Leadership

Streamline CMC Development With Compass BIO

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