Being part of a highly regulated industry, pharmaceutical companies have a particularly difficult task of complying with a myriad of rules and regulations such as US Food and Drug Administration (USFDA) and the European Medicines Agency (EMA) across all aspects of the business. The number and complexity of regulatory requirements have increased substantially over recent years, and the trend is set to continue in the near term. Being the cynosure of public and federal agencies, pharmaceutical companies need to make sure that they have defined and robust compliance practices in place. Identifying, analyzing, and mitigating compliance risks are essential in developing an effective compliance program and ensuring the future sustainability of the industry.
Pharmaceutical companies face particular compliance challenges as they seek to push boundaries of innovation, developing and launching new products which address unmet patient needs, but for which there are often little or no regulation. Adoption of digital technologies such as automation and machine learning can help compliance maintain its position as a strategic partner to the business. Digital technologies can make it possible to move away from mechanical tasks, keep up with the growing amounts of data, and transform compliance into a value-creating organization that anticipates what can go wrong and prevent it from happening.
Besides, holistic compliance solutions untangle intricacies in patent, product, and supplier management functions and enable pharmaceutical companies to pass stringent tests of regulatory bodies. These solutions also help companies embrace new-age technologies like cloud, big data, and analytics while proactively mitigating risks. It allows companies to manage their processes easily and subsequently enhance their workflows. Hence, the pharmaceutical industry is diligently identifying areas across the regulatory value chain that can potentially be centralized and harmonized to achieve compliance faster using cost-effective methodologies.
Understanding the changing times, Pharma Tech Outlook has compiled a list of Top 10 Compliance Solution Providers to guide companies associated with the pharmaceutical sector in harnessing the power of technology to leverage digital capabilities in compliance and address myriad of regulatory requirements, reduce risks, and increase efficiencies, while simultaneously broaden treatment options and help improve patient health.
In this edition, we are glad to feature Cincinnati-based Compliance Insight as a solution provider that brings in-depth experience in pharmaceutical regulatory consulting, product development and quality systems services to developers and manufacturers of pharmaceutical products, helping them develop products safely and confidently deliver them to consumers.
With several innovative technological capabilities and success stories up its sleeves, these Organizations are constantly proving its mettle in the field of compliance for pharmaceutical companies. We hope this issue of the Pharma Tech Outlook helps you build the partnership your firm needs to address their compliance needs better within the silos of individual operations or business functions.
We present to you Pharma Tech Outlook’ “Top 10 Compliance Solution Providers - 2019.”