Resources

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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