A Helium a day…

Regulatory

Analytical Technology for Regulatory

The regulatory industry- ranging from Pharma- both bulk drugs (APIs) and dosages (formulations) as well as medical equipment manufacturers are facing newer challenges. These challenges are in the enforcement of stricter and more stringent norms from the regulatory agencies on one side and on the other facing the heat of the pressure to be more competitive in terms of better R&D productivity as well as operational excellence on the shop floor.

We at Helium are finding newer ways of striking this balance as you try and move towards operational excellence without compromising on regulatory requirements.

Regulatory Scenario

A majority of the regulatory processes today face the uphill task of maintaining production and manufacturing practices without overruling any regulatory laws or international standards. The point of having a manufacturing software technology is to ease out this process. However, with the complexity of some of these software it is understandable that a lot of features are left unaddressed and only a bare minimum functionalities are utilized to set the ball rolling.

The highly fragmented nature of this industry is another vital constraint that needs to be addressed along with the others. Starting from Branded players to Generics, from API manufacturers to Formulations Players, from Integrated Marketing Companies to Pure Outsourcers, each of them face a different set of problems.

While some of the fortunes of the industry do fluctuate as a whole, the operational and supply chain challenges are completely different from each other. Starting from managing Demand, to Regulatory Practices and requirements, from Plant Capacity and Efficiency planning to managing the molecule lifecycle, each of them pose a different kind of operational and tactical challenge for these different sectors

Value Addition

Our team takes great pains to understand your specific paint points and bring a sector-specific experience to the table. This team has delivered solution starting from Big Pharma to Generics to Contract Manufacturers helping them better their manufacturing efficiency and supply chain responsiveness.

  • Utilize your process technology to tackle quality standards and constraints
  • Increase product integrity by syncing all your manufacturing divisions
  • Move towards Operational Excellence and GMP using a novel combination of process and technology
  • Preserving History and establishing a zero error cutover strategy and process
  • Migrate towards paperless automation systems by getting all your business process online
  • Technology Transfer to API manufacturing
  • Maintain economy flow without deviating from compliance standards

What we can do?

  • Automate data flow and process flow using MES systems.
  • Creation of user specific dashboards, reports and KPI's for data monitoring
  • Interface development for Quality Control
  • Migrations and upgrades expertise with absolutely no downtime or data loss guarantee
  • Compliance to 21CFR11 standards for development and implementation
  • Comprehensive mapping of Production Management, Batch Management, Product Dispatch, Quality and Assurance, Data Analysis to MES solutions
  • Electronic Batch Records for Process, Maintenance, operations and production
  • Implement modules to enable effective tracking of product family