NanoViricides has signed a consulting agreement with Biologics Consulting Group (BCG) in order to prepare and submit the Investigational New Drug (IND) applications to the Food and Drug Administration (FDA) for approval of its nanoviricides drug candidates to treat different viral diseases.
The success of FluCide drug candidates in pre-medical animal studies has already been reported by NanoViricides. The company is involved in the preparation of FluCide investigational anti-influenza drug. The company will receive guidance from BCG regarding filling of the pre-IND application to successfully complete FDA approval and evaluation process. BCG will assist NanoViricides in scheduling and applying extra pre-clinical development activities that are required for the IND application.
Additionally, the company expects that while submitting the first IND application to the FDA, it should have produced some amount of drug candidates associated to the product under current Good Manufacturing Practices (cGMP) conditions. The company has declared that it will be leasing facilities so as to be able tomeet the cGMP requirements in a specified period.
BCG, an international consulting organization provides guidance about both national and international regulations and helps in commercial developmental processes for producing drug, device, and biological products. BCG has knowledge in product production and testing, facility inspections, regulatory affairs, pharmacology, toxicology, medical trial design and assessment, statistics, and program management.
Source: www.nanoviricides.com