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At Next Breath we value the importance of educating our clients on the latest technology and regulatory guidance. We make every effort that client expectations match their deliverables. We review your requirements, answer your questions and develop a plan to meet your requirement with careful considerations to your budget before work begins.

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ANVISA Certification

Technical Whitepapers – downloadble PDFs

Technical White Paper _ Generic pMDI Product Development _April 2013

Technical White Paper – Ophthalmic Product Development_July 2013

Click on the Informative Presentation title below to download a full PDF

* Exploring the implications of new regulatory guidance for testing nebulizers

Click on the Publication title below to download a full PDF

* Next Breath PDF

Click on the Regulatory Information title below to download a full PDF

* Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products

* Analytical Procedures and Methods Validation

* Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products — Chemistry, Manufacturing, and Controls Documentation

* ANVISA-Guidance for Pharmaceutical Equivalence and Bioequivalence of Nasal Sprays and Aerosols

* Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action

* Statistical Information for In Vitro Bioequivalence

* Handling and Retention of BA and BE Testing Samples

Click on the Testing Information Sheet title below to download a full PDF

* Applications for Droplet Sizing

* DPI Product Development and CMC Documentation

* MDI CMC Documentation

* Nasal Spray Bioequivalence

* Nasal Spray CMC Stability and Batch Release

* Nebulizer 510K Study