Top 10 Pharmaceutical Compliance Solution Companies - 2019
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Top 10 Pharmaceutical Compliance Solution Companies - 2019

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.”

Top Pharmaceutical Compliance Solution Companies

ClearDATA was conceived and designed from the ground up to serve the mission-critical system needs and regulatory requirements of healthcare organizations. Healthcare professionals across the globe trust the ClearDATA HITRUST-certified cloud to safeguard their sensitive data and power their critical applications available across the major public cloud platforms. ClearDATA’s innovative platform of solutions and services protects customers from data privacy risks, improves their data management, and scales their healthcare IT infrastructure, enabling the industry to focus on making healthcare better by improving healthcare delivery. The founders of the company drew upon their own experience to create the most robust, secure, reliable, and HIPAA-compliant cloud computing solution in the industry

www.cleardata.com

Compliance Insight helps businesses overseen by the FDA navigate the regulatory process, achieve compliance, and develop best practices for the manufacture of innovative drugs, medical devices, and biologics. For many years, the company has been working with the FDA and industry thought leaders on the most important issues that the life sciences industry is facing. Also, the company is leading a collaborative effort with Xavier Health, Cincinnati, Ohio to generate a Roadmap for AI implementation. This will involve industry thought leaders and the FDA working together to develop case studies, a maturity model, and risk analysis to create a basic roadmap for implementing AI in the manufacturing environment in a systematic manner

www.compliance-insight.com

Framework Solutions offers superior services and solutions to the pharmaceutical and life science industry. The company is the leader in the area of promotional and medical review. Framework Solutions Strategic Services group, with its in-depth industry knowledge, will transform your business process through targeted strategy, insight & analytics. The company’s on-demand solution allows you to scale your business more efficiently and cost-effectively. Utilizing their Promotional & Medical Review (PMR) Dashboard will enable them to quickly view the overall status of their digital assets and where they are in the process

framesol.com

Verisys is the leading provider of the most comprehensive health care data, coupled with deep health care industry experience to provide the data through agile technology used to screen, verify, monitor for credentialing, enrolling, and hiring the individuals and entities in the health care sector. Verisys helps organizations understand the complexities of health care credentialing and the importance of access to sanctions, including disciplinary actions and the implications of licensing requirements. The company’s tools are designed to maximize these organizations’ data results to ensure the hiring of safe, adequately credentialed team members

verisys.com

Ideagen Plc

Ideagen Plc

Ideagen Plc provides market-leading information management, safety, risk, and compliance software solutions that allow organizations to achieve operational excellence, regulatory compliance, and reduce risk. The mission of the company is to enable their clients to improve their organizations by providing the tools which can help improve customer service, increase efficiency, reduce risk, enhance compliance, and lower costs. Ideagen Plc’s extensive portfolio of solutions ranges from audit and risk management, document management and workflow, capture, process mapping, order communications, infection control, electronic medical record, and ED Management

IQVIA

IQVIA

IQVIA is a world leader using data, technology, advanced analytics, and expertise to help customers drive healthcare - and human health - forward. Quintiles and IMS Health have come together to become IQVIA, the Human Data Science Company. The company is enabling a more modern, more effective, and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes. Inspired by the industry IQVIA caters, the company commits to providing solutions that enable life sciences companies to innovate with confidence, maximize their opportunities, and ultimately drive human health outcomes forward

OpenText

OpenText

OpenText is the leader in Enterprise Information Management software and solutions that enable intelligent and connected enterprises by managing, leveraging, securing, and gaining insight into enterprise information, on-premises, or in the cloud. The company’s EIM products enable businesses to grow faster, lower operational costs, and reduce information governance and security risks by improving business insight, impact, and process speed. OpenText powers digital transformations to empower the Intelligent and Connected Enterprise. Enabling companies to digitize processes and supply chains and discover value in their information with analytics and Artificial Intelligence, the company offers greater business insight to make data-driven decisions for success

rfxcel

rfxcel

rfxcel is the pioneer and leader in track and trace solutions for the Life Science, Food and Beverage, and CPG Industries. The company develops enterprise solutions to ensure customer success and secure their business. rfxcel specializes in product serialization, traceability, and compliance to provide the most accurate data to meet global government requirements and protect brands. Founded in 2003, rfxcel is the first company to focus on the safety of the pharmaceutical supply chain and bring advanced track and trace software to manufacturers, repackagers, wholesalers, distributors, and dispensers. The company’s mission is to be the thought leader in traceability technology and to enable customers to manage their business better today and deliver value tomorrow

SPI Pharma

SPI Pharma

SPI Pharma understands the challenges our customers face in developing patient-friendly dosage forms that are effective, reliable, and safe. The company’s mission is to be a leading supplier of solutions to pharmaceutical formulation marketers worldwide. SPI Pharma serves over 55 countries with formulation innovation, technical assistance, and troubleshooting support. For over 75 years, the company has supplied the pharmaceutical industry with highly engineered products and innovative solutions that improve the formulation and delivery of drug products to meet patient needs. SPI Pharma focuses solely on the pharmaceutical market, ensuring our best-in-class products provide exceptional quality by meeting or exceeding global regulatory requirements

Verisk Analytics

Verisk Analytics

Verisk 3E delivers intelligent compliance solutions that empower companies to reduce risk, drive continuous improvement, and create new growth opportunities. The company is deeply committed to serving more than 5,000 customers worldwide, including eight of the world’s top ten chemical manufacturers, nine of the world’s top ten retailers, and nine of the world’s top ten pharmaceutical companies. For 30 years, Verisk 3E has provided clients with the expertise, content, live 24-7-365 environmental health and safety (EHS) support and award-winning solutions required to increase chemical and workplace safety, improve product safety and stewardship, strengthen supply chain stewardship, and optimize research and development decision support