Contract research organization Next Breath has announced that it has been certified as a Center for Pharmaceutical Equivalence (EQFAR) by the Brazilian National Health Surveillance Agency (ANVISA) subsequent to a week-long audit of its quality systems by ANVISA conducted in November 2013. The certification means that Next Breath is now the only laboratory outside of Brazil authorized to conduct in vitro pharmaceutical equivalence testing of generic OINDPs for submissions to Brazilian authorities.
Next Breath President Julie Suman commented, “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, Next Breath Associate Director of Business Development added, “ANVISA’s certification is an important milestone for Next Breath. The ability to support our partners will be greatly enhanced with Next Breath’s direct engagement of ANVISA.”
