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.

Our Industry Expertise

Next Breath specializes in analytical testing of drug delivery systems for inhalation and nasal products, extractables and leachables.

NextBreath inhaler

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.

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 in Numbers

0
CERTIFICATIONS
25
TECHNICAL TESTS
0
SUPPORT STAFF
50
MACHINES