Successful submission of a complex NDA for a Pneumococcal conjugate vaccine for the NHRA in Bahrain
Our client, headquartered in the USA, is a mid-sized biopharmaceutical company specializing in clinical-stage precision therapeutics as they work to meet the needs of patients suffering from oncology and autoimmune related diseases.Our client, a top 5 global pharmaceutical company, has partnered with Navitas Life Sciences to support their Regulatory Submissions Management, including dossier management activities, new applications, and maintaining current authorizations for US, EU, AFME, APAC, EME, and LATAM markets.
Our Dossier Management team were asked to support the client with a high priority New Drug Application (NDA) submission to the National Health Regulatory Authority (NHRA) in Bahrain. The submission was complex, owing to the 22 drug substances available in the product. Required as an electronic Common Technical Document (eCTD), the expectation was that the client would be ready to dispatch and launch the product to meet their stringent timeline.
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