Investigational New Drug (IND) Application Regulatory Services

Emerging innovations in science and technology have opened new avenues for the development of several novel drugs and advanced therapies, intended for the treatment of various life-threatening diseases and health conditions. This innovation goes hand in hand with Drug discovery services and Drug development services. In recent decades, there has been a significant increase in incremental innovation and investments in the Biopharma sector towards research and the development of new drugs. Hence, it is expected that there will be a significant increase in the number of Investigational New Drugs (INDs), Investigational Medicinal Product Dossier (IMPDs), Clinical Trial Applications (CTAs), New Drug Applications (NDAs), Biological License Applications (BLAs), IND Publishing Service, IND Submissions Module, CTA Regulatory Submissions under various therapeutic categories in future years. Applications are expected under various categories, including. anti-cancer drugs, precision therapies, tissue & stem cell-based therapies, and gene therapies. and so on.

Many innovator companies face delays in product registration and lose time due to a lack of proper understanding of the Regulatory requirements specific to their case. Without a proper Regulatory understanding and the right partner to aid them during the product development stage, companies often face difficulties in clearing Regulatory hurdles while registering new products. Sponsors may be required to generate additional data (including additional clinical studies) which leads to investments of money and effort and delays, too.

Therefore, support from the right partner during the product development stage is the key to the successful registration and commercialization of innovative pharmaceutical and biological products. Freyr is a global Regulatory company with extensive experience in product development and supports IND developments for Biologics and Pharmaceuticals.