Clearing Phase III trials signifies that a product is more than likely to get FDA approval. And after it gets FDA approval, it can be marketed and sold to patients. Businesses can be built (or acquired). And companies, shareholders, and investors can earn millions of dollars in sales and profits.
However, Phase III approval also brings a growing number of operational and informational challenges, including:
In order to achieve substantial and sustainable performance improvements following Phase III approval, Life Sciences companies must look to optimize their workstreams, technologies, strategies, and people.
Merit Solutions enables Life Sciences organizations to transform their business with MAXLife, a robust and pre-configured Microsoft Dynamics AX solution that is deployed in the cloud using Microsoft Azure. MAXLife consists of pre-built business process models, industry-specific documentation, implementation templates, and integrations with top vendors – creating a preconfigured solution that can be “dropped in” with standard configurations or used as an “accelerator” for global deployments.
Learn more about MAXLife for Life Sciences.
Merit Solutions has extensive experience partnering with pre-commercial and rapidly growing biotech and pharmaceutical companies to enable a smooth transition and successful launch to market once they’ve been approved. We enable these companies to streamline processes and implement compliant, integrated, and validated solutions for ERP, Quality Management, Document Management, Mobility, and more!
Through our industry-tested combination of front end process consultants, back end technology practitioners, and industry Subject Matter Experts, we have the expertise to help Life Sciences companies manage risk, ensure operating performance, maintain compliance, and pursue global growth opportunities. Our broad range of Life Sciences consulting services and IT solutions help address the challenges related to traditional processes, cultural resistance to change, and less scalable technologies – enabling successful improvement projects while operating in a globally regulated environment.
Rapidly growing organizations and those expecting Phase III approval typically experience the following results from partnering with Merit Solutions for success:
Merit Solutions helps our life sciences clients drive their business, process, and enabling systems changes required to achieve their strategic vision and goals. This includes everything from future state business process mapping to systems analysis, fit-gap process definition and scoping, sourcing, design and deployment, integration with other systems, on-going support, and systems validation.
To deliver optimum customer satisfaction, operational performance, and business success – organizations must be able to provide products and efficiently capture, access, and share operations data in the right way with the right entities.
Becoming a lean organization is not a single step or even a finite undertaking such as a typical project. Adopting lean must be a journey that the entire organization takes as a unit.
Even before you receive your 510(k) approval, you should be using an ERP system to help you develop and document your procedures, track costs, plan materials and monitor product structures.
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