Go to Market
Faster & More Reliably
Next Breath, a specialty company of Aptar Pharma, provides comprehensive solutions for the product development process from CMC support to finished batch release and post approval stability to regulatory agencies worldwide.
Our Industry Expertise
Nasal
Next Breath uses the latest instrumentation and methodologies to provide our customers with the highest quality of analytical analysis of nasal drug products.
Inhalation
Next Breath inhalation testing services cover the entire product development process from CMC support to finished batch release and post approval stability for submission to regulatory agencies worldwide.
Extractables & Leachables
Next Breath scientists utilize the latest instrumentation and methodologies to provide customers with the highest quality of analytical analysis of extractables & leachables.
Global Experience
Next Breath has a wealth of regulatory experience with a proven track record of working with regulatory agencies across the globe.
Qualifications & Instrumentation
Next Breath’s world-leading scientists provide bespoke services using the latest instrumentation to you for the next phase of the drug development journey.
Our Values
Next Breath is built on a solid foundation of mutual respect and trust. We approach everything we do with a collaborative spirit and ‘can do’ energy.
Our Industry Expertise
Next Breath specializes in analytical testing of drug delivery systems for inhalation and nasal products, extractables and leachables.
From Next Breath’s full-service cGMP-compliant laboratory, we provide bespoke pharma solutions across the entire product development process from CMC testing to finished batch release and post-approval stability. By approaching each step along the way with a regulatory mindset, we use our expertise and deep experience with agencies around the world to de-risk the development process.
- Routine Tests
- Method Development & Validation Services
- CMC
- Extractables and Leachables
- Bioequivalence Tests
- Regulatory Support
- Stability Studies
Technical Services
CMC
Our CMC lab offers comprehensive CMC testing services using the latest instrumentation and methodologies for metered-dose inhalers (MDIs), dry powder inhaler (DPIs), nebulizers, and nasal inhalation products.
Stability Studies
Our scientists utilize the latest instrumentation and methodologies to provide customers with the highest quality of analytical analysis of MDI’s, DPI’s, nebulizers, and nasal drug products.
Bioequivalence Tests
Next Breath provides certified bioequivalence services, working closely with our customers on abbreviated new drug applications (ANDA) Submission to “Get it right the first time”. We know that demonstrating bioequivalence is more than just lab work.
Method Development & Validation
Next Breath provides comprehensive solutions for the product development process from pharmaceutical formulation and CMC testing, to finished batch release and post-approval stability for submission to regulatory agencies worldwide.
Regulatory Support
Working closely with partners at every stage, we adopt a rigorous, regulatory stance to ensure the requisite product stability and quality standards are met. This diligence and expertise critically improves ANDA Submissions bioavailability and bioequivalence documentation.
Routine Testing
Next Breath provides comprehensive solutions for the product development process from formulation and CMC support, to finished batch release and post approval stability to regulatory agencies worldwide.
Latest News & Events
FEB
22-24
2022 R&D Conference | San Francisco, CA
The 4th international conference on PharmScience Research & Development. Next Breath will be attending.
Next Breath Announces Injectable Extractable and Leachable Services
Baltimore, Maryland – January 19, 2018. Next Breath, a division of AptarGroup, Inc., is pleased to announce the extension of their cGMP analytical services to include development services for injectable delivery systems, with a core focus on extractables and leachables.
Brazilian National Sanitary Surveillance Agency (ANVISA) Certifies Next Breath as a Center for In Vitro Pharmaceutical Equivalence
Baltimore, USA – March 28th, 2014 – Next Breath is pleased to announce that the Brazilian National Sanitary Surveillance Agency
