Due Diligence Assessment of ANDA - Overview
Due diligence assessment involves a detailed review of the existing data, Regulatory strategy, and study plans for the generic drug product per the Health Authority (HA) requirements. Following a proper process can help minimize future risks or hurdles, from the drug development stage to the Abbreviated New Drug Application (ANDA) approval.
Freyr provides Regulatory support in US FDA due diligence services like due diligence of branded generic pharmaceuticals for all HA submissions, along with the development of ANDA submission strategies and risk-mitigation plans to avoid any potential compliance risks throughout the product’s lifecycle.
Due Diligence Assessment of ANDA - Expertise
- Regulatory consultation and pre-submission support for a generic drug application.
- Regulatory assessment of dossiers against the US FDA requirements.
- Gap analysis of the ANDA to identify the potential gaps and anticipated queries from the US FDA.
- Ensuring compliance with the RTR standards.
- Mitigation strategies for the gaps identified through FDA due diligence in the draft ANDA.
- Preparation of effective strategies for the HA submissions as per the Regulatory requirements.
- Regulatory expertise in on-time communication or interactions with the HA so sponsors understand the HA queries better.
