Regulatory Support
Support that Delivers Regulatory Approvals
Working closely with partners at every stage, Next Breath 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. Next Breath is regulatory and cGMP oriented with a proven track-record of working with regulatory agencies to ensure a high product approval rate. After all, efficient regulatory approval is our shared end goal.
Global Regulatory Experience
United States
- FDA Draft Guidance, Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products - Quality Considerations Guidance for Industry, April 2018
- Draft FDA Guidance on Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action, 2003
- FDA Guidance for Industry: Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products—Chemistry, Manufacturing and Controls Documentation, July 2002.
- FDA Drug Product Specific Guidances
- United States Pharmacopeia (USP) <601>, Aerosols, Nasal Sprays, Metered-Dose Inhalers and Dry Powder Inhalers.
Americas
- Ministry of Health, National Health Surveillance Agency – ANVISARESOLUTION OF THE COLLEGIATE BOARD - RDC Nº 278, OF APRIL 16, 2019
- Federal Commission for the Protection from Sanitary Risks, Guide of Interchangeability Studies of Drug Products Administered by Inhalation Route, 2017
- D.R. Council of General Health, Guide of Interchangeability Studies of Drug Products Administered by Inhalation Route, Edition August 2017
Canada (Health Canada)
- Guidance for Industry, Pharmaceutical Quality of Inhalation and Nasal Products, Health Canada, 2006.
India
- Guidance for Industry on Preparation of Common Technical Document for Import/Manufacture and Marketing Approval of New Drugs for Human Use, 2010.
EU (European Medicines Agency) & Australia
- Guideline on the Pharmaceutical Quality of Inhalation and Nasal Products, EMEA 2006.
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