We respect and trust people
- We believe in the self-worth of individuals regardless of their status
- We strive for relationships that are based on openness, honesty, and feedback
- We promote teamwork and cooperation at all levels
- We challenge people to develop their potential and to take initiative
- We practice business relationships that are based on responsibility and on long-term and mutual interests to all stakeholders
Next Breath has a proven track record of working with regulatory agencies to ensure a higher product approval rate and has established strong regulatory relations within the United States, Europe, Canada, India and the Americas. Learn more about our regulatory expertise.
Next Breath is a member of the Aptar Pharma group, and a full service cGMP compliant laboratory specializing in analytical testing of a range of drug delivery systems from early stage to commercialization. We provide comprehensive solutions for the product development process from formulation and CMC support, to finished batch release and post approval stability to regulatory agencies worldwide. Learn more about our services.
Providing Global Regulatory Expertise with Individualized Customer Attention
Next Breath is a speciality company of Aptar Pharma and a cGMP compliant laboratory located in Baltimore, Maryland. Next Breath is viewed as an intellectual leader in the field of inhalation and nasal spray development, testing and regulatory strategy. Next Breath is an active member of the OINDP community. We participate in seminars and educational workshops at leading conferences (RDD, DDL, IPAC-RS, AAPS and PDA among others). Next Breath also regularly contributes to development of standard practices through leadership in the Inhalation and Nasal Technology Focus Group, OINDP and PDA committees
Since inception, Next Breath has collaborated with over 65 pharmaceutical companies and has contributed towards several successful regulatory submissions in domestic and international markets. Our expertise and results have been used in NDA’s, ANDA’s, 510(k) studies and BLA’s. In addition, Next Breath’s FDA inspected laboratory performs commercial batch release and stability studies for the US market.