NanoViricides hires Biologics Consulting to help with FDA submissions process

Biologics Consulting Group (BCS) has signed an agreement with NanoViricides to help in the preparation and submissions process with the Food and Drug Administration (FDA) as the Connecticut-based pharmaceutical company looks to move several of its new anti-viral drugs out of the research and development stage and onto the commercial market.

NanoViricides said it anticipates several submissions after pre-clinical animal studies of its FluCide vaccine were successful. The company also said it was on schedule to develop the anti-influenza product into the investigation new drug (IND) stage with BCS, who will facilitate the review process.

The Virginia-based BCG is an international consulting company that provides regulatory and product development advice for the commercialization of drugs, biological and medical device products for the healthcare sector. The company offers regulatory consulting along with product manufacturing and testing, program management, facility inspections and clinical trial design and evaluation.

NanoViricides said that BCG will assist in the design and implementation of additional pre-trial activities that will be needed for the IND application. The company said it is in the process of securing leasing arrangements with laboratory facilities for the additional studies.