USFDA Formulation R&D Firm looks for a regulatory compliant digital solution

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The Brief:

The Client had developed & scaled formulations for pharmaceutical products in oral solid dosage forms. Yet, due to manual processes in place, their product development was often delayed and so was getting a US-FDA registration.

There was an immediate requirement for an efficient and agile digital solution that wouldn’t risk regulatory compliance.

The Solution:

Archimedis Digital proposed the implementation of an open-source solution, Enterprise Management Platform (EMP).


  • Establish Foundation: The initial phase included a thorough assessment of the requirements of the client. A test version of EMP* was deployed for incoming materials and dispensing

  • Iteration Phase: Based on the feedback received from the client, the platform was tweaked. The platform went through numerous iterations to ensure custom capabilities and the best fit for organizational processes.

  • Empower the Workforce: The client’s workforce was trained to completely understand the digital processes and simultaneously shift from manual to digital. This was ensured to avoid delay in the execution of any core functions.

  • Scale and support: The deployed capabilities were scaled to move away from outdated processes. Archimedis Digital set up a support center dedicated to ensuring the transition to the new digital solution in place was smooth.


  • Compliance Ensured: Assured compliance throughout the business processes which was challenging to achieve with previous manual systems

  • Cross-Department Integration: Departments with the aid of the digital solution now operated in collaboration with each other instead of operating in silos. This ensured seamless workflows from order to delivery.

  • Enhanced supervision and productivity: The implementation greatly enhanced management’s visibility and individual accountability. As a result, this enhanced the company’s overall productivity.

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