Navitas Launches Latin American Regulatory Operations Hub

July 6, 2015

Company News Release

PRINCETON, N.J., July 6, 2015 /PRNewswire/ -- Navitas, a leading Regulatory Service provider, today announced that it has opened a new Latin America hub in Bogota, Colombia. Navitas' expansion into Latin America will take advantage of the many benefits provided by Colombia, the third largest economy in Latin America.

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Colombia's location, allows US based clients to communicate with Navitas regulatory professionals in close to or the same time zone and Colombia is easily accessible from U.S. airports. It enables easy access to any Latin American client and provides good infrastructure, a rich talent pool of professionals with a deep understanding of local and global regulatory requirements. With bilingual resources (Spanish and English) clients can communicate with Navitas regulatory professionals easily and in their native language.

The Latin America hub will provide document, report and submission level publishing for simple and complex submission applications including life cycle management. Navitas also provides invaluable subject matter expertise in evolving electronic submissions standards, health authority specific guidelines and processes.

Additionally, License Maintenance services for marketed products can be effort intensive and difficult to manage at optimal costs. Navitas provides continuous and cost effective support to Regulatory Operations in authoring and submitting variations, renewals and annual reports for marketed products across the world.

Navitas has more than a decade of experience in Labeling & Artwork management. We provide support to the industry's thought leadership in Labeling through labelNet�. We provide cost effective labeling maintenance, coordination and proof reading expertise from our delivery center in Chennai as well as the new Latin America hub.

Navitas becomes an extension to a client's own Regulatory function as a true partner Our Functional Service Provider model enables us to be highly flexible and respond rapidly to customer requirements. Our state of the art Global Delivery Centre (GDC) in Chennai, India as well as the new Latin America hub enables us to deliver process outsourcing at scale and cost effectively. Our unit pricing approach provides visibility, control and efficiency.

For one client, Navitas' regulatory operations group delivers around 15,000 -18,000 submission per annum completed by trained publishers who can publish submissions across global requirements while providing "follow the sun" coverage. This flexibility also includes a training buffer that can provide additional resources to manage a surge in workload.

With locations at client sites, our GDC in Chennai and now the Colombia hub, Navitas can offer clients a true, follow the sun productivity approach.

For more information, contact Patrick Mullen at 609 454-7753

About Navitas

The Navitas team has been assembled bringing together the proven expert teams of TAKE Life Sciences and WCI Consulting and, adding to this core, a range of experts from the worlds of Clinical Development, Regulatory, Technology, and Consulting.

We have built the Navitas team specifically to deliver insight to our clients, to develop pragmatic solutions together, and to support their deployment and operation. We deliver advice, solutions, and outsourcing services in Clinical, Regulatory, Safety, and Content Management.

We are proud that our legacy businesses have served the sector for some 15 years and have allowed us to work with 100 of the top Life Science companies. Our team has now grown to over 500 staff. For more information, visit www.navitas.net

 

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