Through the BLA, promising biological medicinal products can be developed and approved to prevent and treat a wide range of serious, chronic diseases and conditions. That is why biopharma companies are working on new biological products to fill a void in the healthcare industry. Applicants face a difficult decision when deciding on a development strategy for submitting a Biologics License Application (BLA) to the US Food and Drug Administration (FDA).
Health Authorities (HAs) have begun implementing risk-based review procedures in response to the increasing regulatory enforcement for complex biologics/biosimilars and advanced therapies like cellular and gene therapy products. Because of this, an extensive list of complex submission requirements has been issued. Therefore, there is always the risk of failing to include all required details in the Biologics License Applications, which could result in a refusal to file (RTF) with the US Food and Drug Administration. As a result, BLA sponsors favor collaborating with a Regulatory partner with experience providing Regulatory consulting services for biologics and biosimilar products.
From pre-BLA/BPD meetings to post-approval Lifecycle Management (LCM) activities, E&E Medicals provides full regulatory support to BLA sponsors.