Navitas Life Sciences - Driving a new normal in Regulatory Services

Rapidly changing medical affairs sector

When COVID-19 in early 2020 evolved into a pandemic, it jolted the life sciences industry into action. The Pharma & biotech Industry and the Regulators globally recognized the need for deliberate action and responded by prioritizing resources and activities with a focus on finding a cure for COVID-19.

The global pharma industry and regulators became the center of attention. The industry responded with speed, agility and diligence to get NDAs for safe & effective vaccines submitted to regulators worldwide. The global regulators responded with equal urgency and executed their reviews with the highest priority without compromising on the required diligence. The result was approvals of new vaccines within timeframes that had rarely been experienced before. Within a few months, Industry & Regulators together, put the most powerful weapon in the fight against COVID-19 in the hands of the public health systems globally.

During this period drug development and the approval of new drugs became a mainstream topic and went viral. Suddenly everybody had their views on NDA fillings, benefit-risk, efficacy, and time needed to bring a safe and effective product to market or to ramp up manufacturing capacity. Views based on a complete lack of understanding of the extraordinary efforts and prioritization the Industry and the Regulators were pulling off.

Rethinking Strategies

What happened in 2020 was extraordinary. The almost singular focus on getting COVID-19 vaccines to the market meant a huge shift in priorities and resources. In a world where resources are limited, prioritizing one activity automatically means that another activity gets deprioritized. For the Pharma- and Biotech industry the prioritization meant that the normal Product Life Cycle Management activities had to take more of a backseat.

We also need to keep in mind that the industry & regulators were not exempted from the COVID-19 pandemic. We all struggled and continue to struggle with lockdowns, temporary closures, work from home, illness and deaths of colleagues, family & friends. Consequently, we haven´t been able to perform Life Cycle Management activities as we would normally do. Temporarily! Companies will need to refocus their efforts on protecting their products in the marketplace and ensure that changes are managed adequately to ensure patient safety and continuous improvement of Benefit-Risk profiles

Preparing for a new normal

The world is coming to grips with the pandemic and a new normal is on the horizon also for Regulatory and especially Regulatory Operations. What could that new normal look like and how can Navitas support you in achieving a new normal quickly and effectively?

Learn from your peers

Navitas Life Sciences facilitates industry platforms that generate insights, drive internal efficiency using information from expert discussions and knowledge sharing sessions. All aimed at future-proofing Regulatory Strategy and Operations.

Regulatory Industry Networks

The regulatory industry networks include:

A network for labeling professionals; focused on the full lifecycle of labeling

For Labeling Leaders of companies with a specific focus on operational aspects of the full lifecycle of End-to-End labeling

For Regulatory or Labeling IT Professionals; focused on exploring End-to-End Labeling technologies to improve processes and increase business value

A network for Regulatory Information Management professionals to develop best practices and leading-edge solutions for RIM

The regulatory industry networks provide unique benchmarks that can be used to gauge your company’s performance against peers and industry standards. This data helps you identify potential areas for improvement and can be used to develop strategies for transformative change. The benchmark and aggregated data is anonymized, except for individual highlights, thus providing a clear lens into industry practices while ensuring individual privacy.

Manage the change effectively

The Consultants of Navitas Life Sciences support you with the definition of a new normal and will facilitate the transformative change. We take a holistic approach to regulatory processes and understanding the strategies that underpin regulatory compliance in the context of the maturity and product portfolio of your company and the markets that you operate in. We guarantee a fit for purpose new normal which we will implement together.

Experience and Expertise

A single source of the truth

rimREADY Regulatory Information Management is an innovative technology solution that facilitates a single truth of your Regulatory Information. Having the right and trustworthy information will enable you to manage your Regulatory Operations efficiently and ensure global compliance.

Proven capabilities and flexible capacity

An important learning from the pandemic is the need to be responsive to suddenly changing conditions globally. Our regulatory services team has the proven expertise to handle any LCM activity globally and can rapidly flex capacity as needed by your specific requirements. This combination of expertise and flexible capacity is the real value that you need in the new normal.

Navitas Life Sciences provides end-to end regulatory services, starting from support for regulatory submissions to life cycle management.

Navitas Life Sciences helps small to large pharma companies get acclimatized to evolving regulatory requirements and run compliant services, using its vast experience and expertise.

To learn more about our regulatory services, reach out to us at This email address is being protected from spambots. You need JavaScript enabled to view it.

Regulatory Services

• Regulatory Submissions Management - Life cycle Management of approved dossiers including global submission publishing, response to Health Authorities with high quality, compliance
• Labeling and Artwork Management - Harmonization of Global & local label and artwork management process and best practices
• Regulatory Information and Data Management - Leverage our strategic path to RIM excellence
• Regulatory Compliance Management - Adherence to Industry regulations, Implement and maintain the standards and process to ensure patient safety
• Regulatory Resourcing - Access our best talent as per your business requirements
• Expert support for New Drug Application (NDA) filing - Project management roadmap, tracking and monitoring the entire document life cycle until submission to Health Authority
• Product Life Cycle Management - Maintenance of registered dossier with up to date country specific requirements
• Regulatory information management - rimReady is an innovative regulatory information management solution providing single point of truth
• Industry Benchmarks - Gauge your company performance against industry standards and peers