Overcoming Challenges for a Complex New Drug Application for a Pneumococcal Conjugate Vaccine

Navitas Life Sciences is your experienced partner for End-to-End regulatory needs, offering tailored Regulatory Services from Research to Commercialization for both Innovator & Generics sponsors.

Recently we supported a top 5 global pharmaceutical company for Regulatory Submissions Management, including dossier management activities, new applications, and maintaining current authorizations for the US, EU, AFME ((African Middle East), APAC (Asia Pacific), EME (Emerging Markets Europe), and LATAM (Latin American) markets. Our Dossier Management team supported 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, and was required as an electronic Common Technical Document (eCTD).

We met with Meyyammai K, Senior Manager - Regulatory Operations, Navitas Life Sciences, to learn more about the extent of support offered and the challenges that were overcome.

Meyyammai K

Senior Manager,
Regulatory Operations,

Navitas Life Sciences

I am a point of contact for Submission Management projects for AFME and EME regions, which includes 45+ team members and Submission publishing project for US region including 7 publishers.

I have experience in submission management activities like Dossier Planning, translation requirements, Compilation, Publishing, Review, Approval, Dispatch and Archival Submission of Dossier for Initial product registration/MAH application, query response and Post approval submissions (Variation, Renewals, Annual Report, Amendments, Supplements, New Site addition, Withdrawals, PADER, etc.) to US, EAEU harmonization and ROW countries for eCTD/NeeS/Paper type submissions.

You were recently associated with an NDA submission for pneumococcal conjugate vaccine. Can you give us a brief summary?

Pneumococcal conjugate vaccine is a 20 valent protection against pneumococcal diseases like pneumonia. This dossier was a highly complex Major Submission due to the volume of the drug substance which consists of 22 active substances. Since the requirement for this product in the market is high, quick approval and fast market launch was a priority.

There were over 2000 documents with varying modules from the administrative, quality, non-clinical and clinical aspects. The submission process started with dossier compilation, submission outline report review, publish, published output review, County Officer review on dossier output and dossier dispatch to County Office for Health Authority Submission.

What were the challenging aspects of the NDA submission?

The following were some of the challenges faced, which our expert team overcame with knowledge and experience.

• Ancillaries like Good Manufacturing Practice, Manufacturing License & Finished Product Samples due dates were delayed hence frequent follow-up required with the relevant stakeholders
• A challenge was identified based on submission requirements to the health authority. It involved early identification and the need for suitable measures to ensure complian
• Documents were delayed, and a few documents were revised last minute

What unique capabilities did Navitas Life Sciences utilize for successful support?

• There was a unique challenge that we faced regarding submission to the Health Authority. Our prior experience and awareness aided us in understanding a gap. Upon identification, we responded swiftly by alerting the client, who passed our query onto the Health Authority (HA). The response provided by the HA allowed us to pursue on time submission and ensure there were no issues.
• Rolling model in dossier compilation and publishing - Since clinical, non-clinical & quality documents were available with different time intervals, our team compiled the documents and shared the submission outline report with PoC for Approval. This additional effort and time was vital in publishing/reviewing the submission as soon as the documents were available, providing a massive push towards maintaining timelines.

How did we go the extra mile in supporting the client?

Navitas Life Sciences has always focused on customer delight rather than satisfaction. We put in added efforts to ensure seamless collaboration.

• Enhanced communication: A special group was created via MS Teams to communicate with the stakeholders.
• Leveraging Experience to Identify Gaps: Experienced team members who have previously supported projects for similar molecules for other geographical regions were deployed to identify and fix any gaps. This reduced the number of queries from the Health Authority, resulting in faster approval.
• Extensive Review: The rolling model of compilation and publishing allows enough time for PoC to review the submissions prior to HA submission.

What was the client’s feedback or reaction to our support?

We received Appreciation from the client’s Global Regulatory Lead.

What were the highlights/results of the support?

It took only 30 days from the initial handoff from the client to the dispatch of the final dossier to the client’s country office. A massive feat indeed! There were other highlights as well like:

• Overcoming challenges to successfully deliver the dossier ahead of timeline
• High quality & productivity and quick turnaround time with zero defects
• Due to quick dispatch of the dossier, the Submission was made as per the appointment date with Health Authority
• Expected quick approval lead to faster market reach of the product

Have we carried out similar studies before?

Yes, we have dispatched the Dossier for this molecule in US, Canada and many Middle East markets like Turkey, Saudi Arabia, Oman, Qatar, United Arab Emirates, and now Bahrain.

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