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Optimizing an RIM System for Confident Pharma Regulatory Compliance

Notch provided a senior engineering team that fit seamlessly with Amplexor, now ArisGlobal, and helped optimize RIM System. We used Java to establish operational efficiency and reduce tech debt.

CLIENT NAME ArisGlobal
INDUSTRY Pharmaceuticals
TECHNOLOGY Java
SERVICES Team Extension, App Modernization, Custom Software Development
METHODOLOGY Agile, Scrum
DURATION Ongoing
LOCATION Zagreb, Croatia
TEAM NO. 17
The Client

Amplexor Life Sciences, now part of ArisGlobal, provides regulatory, quality, and safety software that helps pharma, biotech, and medical device companies streamline product lifecycle processes, cut time‑to‑market, and boost revenue.

The Challenge

Amplexor/ArisGlobal delivered highly customizable, regulation‑heavy software that demanded continuous testing, audits, and optimization. Clients added new features as needed, while distributed teams in three locations worked with various tools using a waterfall approach.

The Solution

LifeSciences Suite is an end‑to‑end regulatory information management system (RIM platform) that supports full regulatory processes, from research and registration to communication with agencies like EMA and FDA, while also managing quality and product corrections.

Project Goals
  1. 1
    Nightly regressions
    Design nightly regression tests to ensure all customer-specific customizations remain compliant.
  2. 2
    Add new features
    Develop new functionalities and write appropriate tests.
  3. 3
    Platform rewrite
    Create architectural software documentation for rewriting the old platform to new.
  4. 4
    Improve processes
    Navigate the transition to Agile and Lean principles and improve processes.
The Product

LifeSciences Suite evolved into a reliably tested, continuously compliant regulatory information management system. Nightly regression tests secure custom setups for thousands of users, while Agile delivery and senior engineering keep the codebase modern, releases predictable, and audits smooth.

Results

  • 1

    Established operational efficiency with more than 2000 users online at all times.

  • 2

    Satisfied all regulatory requirements adhering to new regulations, features and updates.

  • 3

    Reduced tech debt in the legacy app & product with senior-level engineering expertise.

  • 4

    Improved release predictability and transparency, enabling Agile prioritization of urgent features.