The Due diligence process involves a detailed review of the existing data, Regulatory strategy and study plans of the generic drug product as per the Health Authority (HA) requirements. Following a proper due diligence process can help minimize future risks or any hurdles from drug development to final approval of the ANDA.
Freyr provides Regulatory support in Due diligence services like Due Diligence of ANDA for 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.
Regulatory consultation and pre-submission support for generic drug application
Regulatory assessment of dossiers against the USFDA requirements
Gap analysis of the ANDA to identify the potential gaps and anticipated queries from the USFDA
Assessment for the compliance to RTR standards
Mitigation strategies for the gaps identified on due diligence of draft ANDA
Preparation of effective strategies for HA submissions as per the Regulatory requirements
Regulatory experts help in on-time communication or interactions with the HA and help clients understand the HA queries better