November 30, 2017 Princeton, New Jersey: Navitas Life Sciences, a TAKE Solutions Enterprise, provides services and technology to deliver “first-to-file” results to generic drug companies around the globe, allowing them to bring affordable healthcare to more and more patients throughout the world. Navitas Life Sciences has conducted more than 1000 projects resulting in over 100 Marketing Authorization Holders (MAH) across 6 continents. With over 50 generic and innovator pharma clients, Navitas Life Sciences has over 10 years of proven expertise in bringing generic drugs to market.
While bringing drugs to market, speed is critical, and quality and regulatory compliance are sacrosanct. Navitas Life Sciences’ highly skilled team delivers uncompromised quality of the highest level, along with personalized services. Inspected by the FDA, WHO, Health Canada, EMA, DCGI, TGA & NPC, among other regulators, Navitas Life Sciences provides rapid set-up with tailored multi-analyte methods in 4-5 weeks. Certified to ISO 9001, ISO 27001, and ISO 15189, and accredited by CAP, Navitas Life Sciences has received zero observations in its last 3 FDA inspections.
Navitas Life Sciences also operates multiple study sites with a ready volunteer pool of over 20,000 including special groups, ICU access and 210 beds. Navitas’ full service includes medical writing, eCTD submission services or software, data standardization into company or CDISC standards, along with data archival allows clients to compete while avoiding the high cost of regulatory compliance for accelerated studies. Companies that lack internal capabilities in terms of studies or regulatory compliance, along with a need for ready access to hospital sites can benefit from the complete solution Navitas provides.
Generic drugs, low-cost copies of branded pharmaceutical drugs, have been gaining in volume and market share. Typically priced at significant discounts (50% - 90%) to their branded counterparts, health plans and governments around the world are encouraging and promoting the use of generic drugs. Once a branded drug’s patent has expired, any company can sell a generic version of that drug, but in the US, the FDA grants a 180-day exclusivity period to the company that is the first-to-market, or first-to-file. For a blockbuster drug that generates revenues of over a billion dollars a year, this exclusivity equates to at least $500 million.
Navitas Life Sciences harnesses the combined knowledge and experience of three legacy brands—Ecron Acunova, Navitas, and Intelent, to bring End-to-End R&D solutions to the generic drug industry. With capabilities across BA/BE (Bioavailability/Bioequivalence) studies, clinical data management and pharmacovigilance software and services, Navitas Life Sciences presents global generic companies with a one stop shop of transformative offerings to enable a “first-to-market” advantage.
For more information, visit http://www.navitaslifesciences.com/ba-be-studies
About Navitas, Inc.
As a partner for the industry, Navitas Life Sciences leverages industry insights, consulting and technology capabilities to deliver full service clinical, regulatory and safety solutions and desired outcomes to clients. As the dedicated life sciences brand of TAKE Solutions, Navitas harnesses the combined knowledge and experience of three legacy brands—Ecron Acunova, Navitas, and Intelent—to provide end-to-end services and solutions. Navitas helps clients address their most critical problems by bringing together the capabilities of a full-service CRO, a technology-led life sciences services provider across clinical, regulatory and safety, and a life sciences big data services and analytics provider. Operating from 7 countries across the globe, Navitas works with over 150 customers in the Life Sciences industry.