Global Experience
A Proven Track Record of Regulatory Success Across the Globe
Next Breath has a proven track record of working with regulatory agencies all over the globe to minimize the risk of drug development. Think of Next Breath as a regulatory affairs consultancy – we provide end-to-end product service development with a regulatory perspective. Whether we are helping with product development, formulation services, pre-clinical stability or regulatory filings we approach the testing with a regulatory mind-set.
Next Breath provides comprehensive regulatory support services and have extensive experience working with regulatory agencies across the globe. Our customers can be confident we are up-to-date with the current guidance and regulatory requirements, including:
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- FDA Draft Guidance, Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products - Quality Considerations Guidance for Industry, April 2018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.