Next Breath, an Aptar Pharma Company, is a full-service GMP compliant and FDA registered and inspected laboratory, specializing in the 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.
Accelerating and De-Risking Your Drug Development
Pharma is witnessing an escalation in the complexity of the registration process and a heightened focus on device technology and patient safety from regulatory bodies. To address these gaps, this webinar presents a case study on how Aptar Pharma Services, together with the expertise of Nanopharm, Next Breath and Gateway Analytical, supports customers during the entire life cycle of the drug product and delivers a complete solution.
Presenter: Julie Suman, President, and Co-Founder at NextBreath
Duration: 21 min
Aptar Pharmaceutical Services Overview
This presentation is a brief overview of the Aptar Pharma Services companies and their areas of expertise.
Presenter: Tracey Safran, Business Development Manager at NextBreath
Duration: 8 min
Finding a devoted analytical services partner can often be arduous and in an environment where every minute counts, choosing the right one is critical. Next Breath understands the challenges companies face. We work with customers at each step of the process to ensure not only customer satisfaction but also product stability and quality for meeting regulatory demands in addition to critical support for ANDA Submission and developing the necessary study programs to demonstrate the bioequivalence of your drug product.
- cGMP compliant laboratory, ISO 17025 Accredited and EQFAR certified laboratory through ANVISA
- Registered with FDA (last inspection January 2016 – no 483s)
- DEA license for controlled drug substances (schedule II-V)
- Accredited to ISO/IEC 17025:2005
We have a proven track record of working with regulatory agencies to ensure a higher product approval rate.
- EU & Australia