What’s New

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Ann Grey

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New Healthcare-related Products, Services, and Companies

Parexel Launches Regulatory Outsourcing Service

Trending Now: Regulatory information management solutions to enhance client value.

Parexel, a global biopharmaceutical services provider, has launched a new service line designed to provide a focused, market-driven approach to regulatory outsourcing services in the life-sciences industry, with a primary emphasis on post-approval regulatory activities.

Through Parexel Regulatory Outsourcing Services, the company can customize services for clients based upon their unique needs and business challenges by combining expertise, operational approaches, and technology. The service line resides within the Parexel Consulting business segment.

“With the ever-changing regulatory environment, pharmaceutical companies face new challenges that need to be addressed with efficiency and cost in mind,” says Mark Goldberg, M.D., president and chief operating officer, Parexel. “Clients will now be able to outsource significant portions of their regulatory activities to a trusted partner in a cost-effective manner.”

Rick Riegel, corporate VP and new head of the regulatory outsourcing services line, says regulatory outsourcing is growing increasingly important in the market as more and more companies rely on outsourcing to help them with the complex task of managing their regulatory needs, especially the regulatory maintenance of their marketed products.

For more information, visit parexel.com.


Life Sciences Innovation Initiative

Moravia has launched the Life Sciences Innovation Initiative (LSI), a customized program to promote globalization best practices among medical device manufacturers, pharmaceutical companies, and other healthcare businesses.

Led by Li Murty, director of global life sciences programs for Moravia, the LSI program includes dedicated teams of globalization professionals who are specially trained to support life-sciences clients, in addition to customized materials and procedures to address healthcare-specific issues.

“Healthcare companies have unique globalization challenges that can’t be served with a cookie-cutter approach,” Mr. Murty says. “International and country-specific compliance regulations, complex medical terminologies, wellness and safety issues, and a host of other concerns can’t be satisfied with business-as-usual services. We’ve created the LSI program to address the industry’s specific needs.”

Key components of the program include best practices; proprietary technology solutions with plug-ins customized for life-sciences companies, such as audit trail capabilities and automated QA tools incorporating the client’s standard operating procedures (SOPs) or project-specific work instructions; specialists in emerging globalization trends, including cloud-based solutions, mobile, multimedia, managed services, global search engine optimization (SEO), and other innovations; and objective analysis and counsel to optimize the role of globalization in future growth.


DPx Launches as Global Provider of Pharmaceutical Services, Fine Chemicals and Proprietary Technologies

DPx is the corporate parent of a group of business units comprised of three distinct brands focused on pharmaceutical services, fine chemicals, and products and proprietary technologies. These units are the result of combining DSM Pharmaceutical Products (DPP), Patheon, and Banner Life Sciences.

Pharmaceutical services now operates under the Patheon brand name and includes the commercial manufacturing (CMO) capabilities, pharmaceutical product development services (PDS) as well as biosolutions and biologics (Bio) businesses of DPP.

Fine chemicals, or the ES/IM and active pharmaceutical ingredients (API) businesses, operates under the brand name DSM Fine Chemicals.

Proprietary products and technologies operates under the Banner Life Sciences brand name.

Patheon is the industry’s end-to-end supplier providing an integrated supply chain model to customers. Patheon delivers a full spectrum of pharmaceutical development and manufacturing services ranging from active pharmaceutical ingredients (API), biologics and biosolutions, as well as pharmaceutical product development services (PDS) and commercial manufacturing (CMO) capabilities. Additionally, DSM Fine Chemicals handles complicated APIs and finished dosage forms for customers while Banner Life Sciences offers its own proprietary and nutraceutical products to the market.

“We believe that combining the capabilities and experience of both Patheon and DPP immediately positions us as the pharmaceutical industry’s partner of choice,” says Jim Mullen, CEO of DPx. “Today, we are better positioned to add scale, new value chain capabilities and technologies, as well as expand our end-to-end service offerings to our customers as a global, comprehensive solution provider.”

Around the Globe

Almac has expanded its clinical services and technologies capabilities to include on-the-ground leadership as well as technical, project, and ­operational resources in Asia. The company has established regional hubs in Singapore and Japan to better enable the industry’s growing need to conduct clinical trials in Asia and/or manage global trials from the region.

For more information, visit almacgroup.com.

INC Research, a therapeutically focused global CRO, has acquired MEK Consulting, a clinical ­monitoring-focused CRO based in Lebanon with operations in Greece, Turkey, and the Middle East and North Africa (MENA) region. The move ­supports INC’s strategic business expansion in high-growth regions to deliver global trials for its customers, and positions the company as a drug development partner in MENA, which offers ­access to more than 200 million new patients.

For more information, visit incresearch.com.

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