Celebrating 10 years of partnership for Regulatory Services with a Top 10 Global Pharma

Navitas Life Sciences celebrates 10 years of partnership for regulatory services with a top 10 global phama, aiding them in taking their products to the global market by providing vital support to cater to regional regulatory requirements.

Our rich legacy of experience and expertise, helped us serve as trusted advisors and provide tailored solutions grounded in industry best practices.

Navitas Life Sciences’ Experience

Navitas Life Sciences Aids Pharmas Achieve Regulatory Compliance

Global health authorities regulate and govern the drug development process, and pharmas require regulatroy affairs experts to ensure compliance throughout drug development and beyond. Regulatory affairs need dedicated focus that our experts can provide, while pharmas pursue innovation and drug discovery.

Navitas Life Sciences provides key regulatory affairs support, acting as the essential partner between pharmas and regulators like the USFDA, European Health Authorities and Health Canada. Our Regulatory Strategy team, with over 20 years of experience, can help you navigate the regulatory landscape as trusted advisors, providing strategic oversight, industry benchmarks, and insights. We have vast experience in providing Regulatory Process Consulting for all varieties of submissions globally.

10 Years of Regulatory Support for Top 10 Global Pharma

To understand more about the support offered to the Top 10 global pharma, we met with Mr. Mallikaarjunan, Vice President - Regulatory Services at Navitas Life Sciences for an insight rich interview session. Read on to find out how the expertise of Navitas Life Sciences helped meet the needs of the global pharma, resulting in a long lasting partnership.

Tell us a bit about yourself and your career path

I have been in the Regulatory Affairs/Operations for over 17 years, worked in Pharma companies, CROs, Regulatory focused solutions, and services companies. My position, and training in this field put me at the nexus of product lifelines dealing with End to End Regulatory services (drug development, clinical studies, and post-marketing considerations).

I am currently managing the Regulatory Services group at Navitas Life Sciences, working with top 10 pharma & biotech companies in developing strategies, process standardization and have implemented proven metrics-oriented process-driven function & predictive forecasting / resource plans to manage supply-demand of workforce.

Mallikaarjunan R

Vice President

Regulatory Services at Navitas Life Sciences

What is unique about the regulatory services offered by Navitas Life Sciences

Navitas Life Sciences offers End to End services, supported by a qualified and ready-to-go team. Customers can choose specific services or End to End for IND, NDA and ANDA etc.

Our End to End regulatory services range from Regulatory strategy, Regulatory CMC, Medical Writing, Labeling & Artwork, Publishing and Submission, Handling Health Authority queries and liaising, Data Management, Regulatory resourcing, and Post marketing support.

How do you ensure cost and operational efficiency?

The cost & operational efficiency is managed via resource allocation using ‘’Pyramid model’’, train-the-trainer model, Ready to go bench/back-up strength availability, Flexible sourcing, effective usage of automations in the process, rewarding top performers, project oversight/performance monitoring & tracking.

We have implemented various tools to monitor the projects, trained the resources with multiple skill sets, quickly onboarded onto projects, closely worked with sponsor in terms of process improvement and continuous improvement, improved customer service and maintained compliance by implementing effective governance model to showcase the metrics and continuous improvements.

What are the trends in regulatory services to look out for in 2022?

Regulatory affairs services are paramount from the design of the clinical trials, IND stages through NDA, and post-approval to accomplish First-Time-Right Submissions to global markets. This requires expert services from regulatory strategist, CMC, and Labeling / Promotional specialists.

Navitas with its spread in North America, South America, Europe, APAC, and Australia gives you a global outreach. Normally, companies would have to invest considerably to get such skill sets and widespread reach. At Navitas Life Sciences, you get expertise at a reasonable cost

Do you cater only to mid and large pharma’s?

We provide support to small, mid-sized and large pharma’s.

What are the reasons for the long standing partnership with a top 10 pharma for regulatory services?

Some of the important factors that have helped mould a strong relationship include:

• Effective business model – Onboarding trained resources on time for the respective projects. The availability of trained bench resources to handle additional work volume, or to ensure business continuity when the primary resource is on leave or to replace primary resource.
• Participation and guidance in every step of process automation
• SWAT team to take up any urgent deliverables and to support ad-hoc projects
• Follow-the-sun method to support reduction in the handoff and to deliver the submission within 24 hours
• Dedicated team to support Major/Complex submissions
• Effective project governance structure by adhering to statement of work (SOW) – Operational/Steering committee meetings in place
• Continuously evolving with client operating models like upgrading ourselves in terms of technology and submission delivery process
• Acting as a satellite hub for the APAC region
• Supporting the specific needs of the client. Example: Navitas has set up a state of the art printing & dispatch facility in India to deliver CTD submissions for the APAC region
• Different pricing models, thereby passing on the cost benefits to the client
• Effective evaluation of risk and CAPA management
• Meeting agreed on KPIs / SLA as per SOW

What were the regulatory services provided for the Top 10 pharma?

Below is the list of services that are ongoing for the Top 10 pharma :

• Publishing & Submissions support for global regions includeing Initial and Life cycle maintenance submissions types
• Submission Management support for global regions includes Initial and Life cycle maintenance submissions types
• Data management support for global portfolio
• Clinical Study Report Publishing
• Submission archival management
• CTA (Clinical Trial Application) submission support
• Product licensing support
• Regulatory change management
• Ad-hoc or short term divestiture projects like MAH transfer, Database tracking etc.

Please provide us with anecdotes about how you went the extra mile to support unique needs

Here are some interesting anecdotes

Major Submissions / COVID-19 project:

Successfully delivered submissions for blinded studies through a dedicated SWAT team model operated in a secured closed work environment with controlled access. Our IT team ensured Security monitoring tools on each laptop/desktop and has ensured seamless delivery. Efficient progress and communication was accomplished through the assignment of Navitas Single Point of Contact, maximum usage of automated tools, 24/7 support, Communication and resolutions with client stakeholders through the MS TEAMS channel, etc.

Process Simplification:

We have initiated a Joint working group - Task Force in 2020 as a part of continuous improvement, together conferred the harmonization of the Global SOPs, by removing reductant steps and maximizing the utilization of automation to achieve cost efficiency through effort reduction.

Satellite HUB for client:

The submission management activities start with dossier planning, coordination, compilation, review, and delivering approved dossiers to the respective country office or submition directly to a Board of Health (B0H) via the Health Agency portal. The client requested Navitas Life Sciences to support in performing printing of CD and Paper copies of the dossier and shipping it to the respective country office.

Navitas Life Sciences established a state-of-the-art facility in India that acts as a “Satellite HUB for the client” where all printing of CD and Paper copies of the dossier is performed with shipping of submission dossiers in paper format and CD to various health authorities in the APAC countries (India, Nepal, Sri Lanka, Bangladesh, Bhutan, Pakistan, Afghanistan).

By performing these printing and shipping services, Navitas Life Sciences performs end-to-end submission management activities, which is cost-efficient for the client, support business continuity and also helps the client to concentrate on core activities.

How did you cope with business continuity for your partners during the COVID-19 pandemic?

• We initiated business continuity plan (BCP) well ahead i.e before lockdown was announced by local government
• Laptops with data card/WIFI hotspot were provided to the team members
• Navitas IT set up is enabled with multiple internet service providers (ISP) to provide seamless network to access client tools via Citrix, AWS etc.
• We created SWAT team, available 24/7 to provide any urgent support. All communications were through MS teams channel, IM etc.
• Project Managers/Team Leads ensured that the submissions were executed and delivered on a daily basis, across locations.
• We created a resource back up plan in case of power outage and technical glitch during the BCP
• Daily project catch up meeting was scheduled to review the work/submission status with workload managers, and the submission status was reported to the client stakeholders
• Weekly project level meetings with customer during the BCP period was conducted to discuss the progress

What are you most proud of in your 10 year association with the top 10 pharma?

I have been a part of this engagement from its inception. My career path is well connected to this project as we started with 12 resources in 2012, and delivered 1000 submissions in 3 months. Gradually we began to provide other services as well, which resulted in the addition of team members across all the delivery centers.

Currently, we have allocated more than 180 people who support various services globally. I have been associated with initiatives such as implementing the combined unit pricing, transitioning submission management work, setting up printing & dispatch HUB in India, etc., Business continuity was seamless during the COVID pandemic due to effective /proactive planning & coordination by the team.

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