Orally Inhaled and Nasal Drug Product (OINDP) Testing and Consulting Services

Analytical OINDP Services Brochure

Analytical OINDP Testing Services Brochure

Gateway Analytical provides a unique set of analytical testing and consulting services for orally inhaled and nasal drug products (OINDP) to support development, quality testing, and submission of information to the FDA.

Whether developing a novel drug product or working to be first to market with your generic equivalent, Gateway Analytical can be an integral partner to your success.

Analysis of Many OINDP Types Including:

  • Nasal spray suspensions
  • Nebulizers
  • Dry powder inhalers
  • Metered dose inhalers
  • Aerosols

Analytical Testing Services Include:

Consulting Services Include:

  • Method development and validation protocol for services listed above
  • Support and guidance for companies going through bioequivalence
  • Failure and root cause analysis
  • Particulate contamination analysis & source determination

Working to Address Critical Path Opportunities for Generic Nasal Spray Suspensions:

Gateway scientists can provide expert support for companies developing generic nasal spray suspension products, using a novel method for measuring ingredient-specific PSD using Raman chemical imaging.

This method, performed in a cGMP laboratory environment, has the potential to address the FDA’s Critical Path Opportunity for direct measurement of particle size equivalence in nasal spray suspensions, possibly allowing for a waiver of in vivo biostudies and savings of millions of dollars in development costs and up to half of the time required for clinical studies.

Contact us for to request a quote or ask for more information regarding our analytical testing services for orally inhaled and nasal drug products.