Expertise & Services

A Partner to Accelerate Your Drug Product Development

Nasal

Nasal

Next Breath uses the latest instrumentation and methodologies to provide our customers with the highest quality of analytical analysis of nasal drug products. We have the technical expertise and experience when it comes to development of nasal inhalation products, including dry powder nasal inhalers.
ABOUT NASAL

Inhalation

Inhalation

Next Breath's comprehensive service offering is specially tailored for inhalation products, including metered dose inhalers, DPI products (dry powder inhalers) and inhalation solution and suspensions.
ABOUT INHALATION

Extractables
& Leachables

Extractables & Leachables

Next Breath scientists utilize the latest instrumentation and methodologies to provide customers with the highest quality of analytical analysis of extractables & leachables.
ABOUT EXTRACTABLES & LEACHABLES

CMC

CMC

Next Breath's 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. At the completion of each project, we provide our customers with detailed reports ready for regulatory submission.
ABOUT CMC

Stability Studies

Stability Studies

Next Breath's 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.
ABOUT STABILIITY STUDIES

Bioequivelence
Tests

Bioequivelence 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. Our customers rely on Next Breath to bring regulatory strategy, device understanding and technical know-how.
ABOUT BIOEQUIVELENCE TESTS

Regulatory
Support

Regulatory Support

Working closely with partners at every stage, Next Breath adopts 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.
ABOUT REGULATORY SUPPORT

Method Development
Validation Services

Method Development
Validation Services

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.
ABOUT METHOD DEVELOPMENT
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