How to provide ‘Outstanding’ Regulatory Compliance Services to a Top 10 Global Pharma

Regulatory compliance stands as the bedrock of operations for pharmaceutical companies, governing their ability to innovate, produce, and distribute life-saving medications while ensuring the highest standards of safety and efficacy. In a landscape where adherence to ever-evolving regulations is paramount, the consequences of non-compliance can be severe. At Navitas Life Sciences, we understand the critical importance of regulatory compliance services to meet regulatory standards.

Our comprehensive suite of pharmaceutical regulatory consulting services is tailored to assist small to large Pharma companies in navigating the intricate maze of regulations and emerging risks. By leveraging our expertise, technology-driven solutions, and collaborative approach, we empower our clients to not only achieve regulatory compliance but also preserve organizational value and gain a competitive edge in the dynamic pharmaceutical landscape.

‘Outstanding’ Regulatory Compliance Services to a Top 10 Global Pharma

A leading global pharmaceutical company commended our support as "Outstanding," highlighting our collaborative approach and teamwork in the successful migration of regulatory files. As the industry continues to advance, embracing stellar practices and efficiencies has become imperative for pharmaceutical companies worldwide.

To shed light on the stellar support for the top 10 Global Pharma, Navaneethan R, Assistant General Manager of Regulatory Operations at Navitas Life Sciences, provides valuable insights into Navitas Life Sciences’ regulatory consulting services, regulatory compliance consulting services, and the impressive work carried out to support the sponsor company.

Navaneethan R

Assistant General Manager of Regulatory Operations,

Navitas Life Sciences

Please elaborate about the project and the role Navitas Life Sciences played?

Navitas Life Sciences partnered with a top 10 global pharma on a special project, which constituted a crucial component of a larger initiative. This project had 2 phases. The first phase of the project was received in November 2022, comprising a comprehensive set of 1115 documents, detailed in an inventory Master file spread sheet. Our task was to seamlessly upload these CMC documents into the GDMS system (Global Document Management System), ensuring accurate metadata alignment with the information provided in the master sheet.

Despite the challenging timeline, our dedicated team completed Phase 1 within an impressive 10-day timeframe, exceeding the initial target of 3 weeks. Phase 2 commenced with the receipt of 3816 documents in September 2023. Once again, our adept 3-member team swiftly mobilized to fulfill the project requirements within a 2-week timeline, seamlessly delivering the desired outcomes without compromising on quality.

Throughout both phases, Navitas Life Sciences assumed the responsibility of uploading all documents into GDMS, meticulously editing metadata, conducting peer quality checks on metadata, and ensuring the promotion of all documents to their final state. Our unwavering commitment to quality was underscored by detailed quality control checks for all document uploads, adhering strictly to the specifications outlined in the Master file.

Effective communication channels established by the Navitas team played a pivotal role in facilitating project progress, ensuring seamless coordination, and promptly addressing any queries or concerns that arose. By maintaining open lines of communication and fostering a collaborative environment, we successfully navigated the complexities of the project, earning accolades for our teamwork and dedication to excellence.

What were the key challenges faced during the collaboration project and how were they overcome?

One significant challenge arose due to the inclusion of document names written in Chinese within the master file. This complexity made it difficult for us to seamlessly upload the documents into GDMS. The team tackled this challenge by meticulously comparing the numerical values in the document names with those listed in the master file. Achieving accuracy in this process demanded a heightened level of attention to detail to ensure the correct first deliverable to our customer for uploading and subsequent QC review. Despite the intricacies involved, our team's diligence and precision enabled us to overcome this obstacle efficiently, demonstrating our commitment to delivering high-quality outcomes.

How did the local team's support contribute to overcoming these challenges?

The local team's support played a crucial role in addressing these challenges effectively. Whenever the Navitas team encountered a query, it was promptly posted in the MS Teams channel, and the sponsor team responded swiftly, providing immediate guidance and clarification. Additionally, clear work instructions were readily available for reference, ensuring quick resolution of any queries that arose.

Furthermore, a weekly meeting was established to monitor the project's status and collaborate on finding solutions to challenges. The joint travel of both teams during the project facilitated seamless communication and alignment, fostering a collaborative environment conducive to overcoming obstacles efficiently. This proactive approach to communication and problem-solving underscored the effectiveness of the local team's support in navigating the project successfully.

How long did it take for you to complete the project?

Phase 1 was completed in 10 days, with the deadline set for 2 weeks. Phase 2 was completed in 15 days, while the deadline set was 3 weeks.

Could you highlight some instances of swift actions and productive communication that played a vital role in the project's success?

Thanks to our clear work instructions, our team encountered few queries, minimizing the need for extensive outreach. We diligently published daily status updates on work completion and reported pending tasks to our client. This transparent communication approach instilled confidence in our client regarding the project's progress, paving the way for a successful outcome.

How did the collaboration with a leading Regulatory Services CRO, like Navitas Life Sciences, enhance the efficiency and effectiveness of the project?

Collaborating with a leading regulatory affairs services CRO, such as Navitas Life Sciences, instilled tremendous confidence in our client, ensuring that their work would be completed well ahead of schedule and with exceptional quality. Our team operates within a structured SWAT model, meticulously understanding and addressing customer requirements while keeping them consistently informed of project status updates and promptly addressing any raised queries. This collaborative effort between the Navitas team and the top 10 Global Pharma team proved highly beneficial once again, reinforcing the efficacy of our partnership.

Please provide us with any feedback from the sponsor organization that highlights the support that we provided.

Clear guidance from customer end made the job easy even though the project is in Chinese language, lead to complete our project without any issues. We have successfully completed the project and below are the multiple appreciations received from the sponsor.

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