505(B)(2)

505(b)(2) Consultants. Regulatory Experts.

inVentiv Health Clinical provides comprehensive support services to help you navigate the challenging 505(b)(2) regulatory pathway. This regulatory approval process leverages existing product assets to save time and money. Whether you’re considering brand extensions or new indications, formulations, or dosages, inVentiv Health Clinical has the strategic expertise to introduce new and improved products and reinvigorate your brands.

Clinical and product development for 505(b)(2) services include:

  • Customized consulting and feasibility assessment
  • Provide strategic considerations and key development steps before embarking on a 505(b)(2) approval route
  • Regulatory support for clinical program development (study design, biostatistics, etc.)
  • Assist sponsors in crafting their CMC and non-clinical program
  • Preparation and writing of pre-IND and IND package
  • Coordination with the regulatory agency for pre- and post-IND meeting
  • Interaction with the regulatory agency
  • IND, NDA, and 505(b)(2) preparation and submission