Pharmaceutical market in the United States of America (USA) is considered the best for its established Regulatory framework. The US Food and Drug Administration (US FDA) regulates the manufacture, import, distribution and marketing of pharma products in the country. The term pharma in the USA overarches numerous products and each of them possess a different approach to obtain market authorization. Pharmaceutical products in the country must be registered with the FDA through New Drug Application (NDA) for an Investigational New Drug (IND), Abbreviated New Drug Application (ANDA) for a generic drug, and through Biologics License Application (BLA) for a new biologic product.
NDAs and ANDAs are further divided into:
- Stand-alone NDA - Submitted under section 505(b)(1) and approved under section 505(c) of the FD&C Act
- 505(b)(2) Application is an NDA - Submitted under section 505(b)(1) and approved under section 505(c) of the FD&C Act
- ANDA - Submitted and approved under section 505(j) of the FD&C Act
- Petitioned ANDA - Submitted and approved under section 505(j) of the FD&C Act
With an extensive Regulatory criterion in existence, it might be challenging for new market entrants to understand and implement the critical aspects related to dossier compilation and submissions while approaching for market authorization with the FDA. With requirement of a US agent for foreign applicants, it may also be a difficult scenario to appoint a dependable person in the region.
With proven Regulatory capabilities, Freyr supports sponsors in ensuring their NDAs and ANDAs compiled and submitted as per the USFDA requirements. Headquartered in USA, Freyr offers strategic and intelligent Regulatory services for successful and on-time submissions for all variants of applications.