Brazilian National Sanitary Surveillance Agency (ANVISA) Certifies Next Breath, LLC as a Center for In Vitro Pharmaceutical Equivalence
(PRWEB) March 18, 2014
Next Breath, LLC, a specialty Contract Research Organization (CRO) with analytical expertise for pharmaceutical, biotechnology, and consumer health product development focused on pulmonary, nasal, topical and ophthalmic delivery systems, is pleased to announce that the Brazilian National Sanitary Surveillance Agency (ANVISA) has certified the company as a Center for Pharmaceutical Equivalence (EQFAR). As a result, Next Breath is now integrated into the Brazilian Network of Analytical Laboratories on Health (REBLAS). ANVISA performed a week-long comprehensive audit of Next Breath's quality systems in November 2013.
The audit focused on ensuring that all quality systems, analytical capabilities, regulatory expertise and statistical capabilities meet ANVISA's rigorous standard for becoming an approved Center for Pharmaceutical Equivalence. The successful audit approves Next Breath for performing in vitro pharmaceutical equivalence and submission of Nasal, Dry Powder Inhalers (DPIs), and Pressurized Metered Dose Inhalers (pMDIs) drug products to the Brazilian authorities.
Only ANVISA certified laboratories are authorized to perform in vitro pharmaceutical equivalence testing. The Center for Pharmaceutical Equivalence certification makes Next Breath the only laboratory outside Brazil certified to perform in vitro pharmaceutical equivalence testing for use in the Brazilian market.
Julie Suman, R.Ph., Ph.D. President said, "Next Breath has been committed to working with ANVISA and our Brazilian partners for many years. Recognition as an EQFAR laboratory allows us to bring our scientific expertise and know-how to advance generic drug approvals. We are very pleased with this certification."
Badre Hammond, MBA, Associate Director of Business Development stated, "ANVISA's authorization is an important milestone for Next Breath. We will continue our ongoing efforts to reach new and geographically diverse partners in this space. The ability to support our partners will be greatly enhanced with Next Breath's direct engagement of ANVISA."
ANVISA
ANVISA is a regulatory body of the Brazilian government. It has a role similar to that of the FDA in the United States, and is responsible for the regulation and approval of pharmaceutical drugs. For more information, please visit: portal.anvisa.gov.br/wps/portal/anvisa/anvisa/home.
Next Breath
Next Breath, a member of AptarGroup, is a cGMP CRO for pharmaceutical, biotech and medical device companies that bring pulmonary, nasal, and ophthalmic drug products to market. Next Breath provides comprehensive solutions to the development processes from proof of concept to commercialization. Next Breath has led successful submissions for pulmonary and nasal drug products and devices in the US and international markets.
For more information, please visit http://www.nextbreath.net or http://www.aptar.com.
Next Breath Contact:
Badre Hammond, MBA +(1)352-642-2141 / badre(dot)hammond(at)nextbreath(dot)net