Strategic Regulatory Consulting
Over 100 Years of Combined Experience in Guiding Sponsors through the Regulatory Landscape
The regulatory landscape is a constantly evolving, one with increasing emphasis on ensuring patient safety. This fluid environment presents challenges to departments whose mandate is to manage and extract value from the vast amounts of structured and unstructured information and data, whilst ensuring their organizations stay compliant with the myriad of global, regional and local requirements. The increased focus on Marketing Authorization Holders’ ability to manage product information as well as their capability to track and monitor safety and benefit-risk information throughout the life cycle of their products, requires organizations to put in place fit-for-purpose and robust systems, processes and governance.
With a consulting team that brings over 100 years of combined experience to help sponsors navigate the regulatory landscape of their organization, Navitas Life Sciences consultants serve as trusted advisors, providing strategic counsel backed by years of experience, industry benchmarks and insights. Our breadth and depth of experience has taught us that there is no one-size-fits-all solution. We take a personalized approach to each client situation to ensure results are grounded in industry best-practices supported by our industry networks labelnet and rimnet, tailored to specific needs, as well as being fit-for-purpose, cost-effective, scalable and compliant.
The Navitas Life Sciences Advantage
100+ Years Combined Experience
Insights from Industry Networks
Whilst our Regulatory Consulting team has a proven track record covering the breadth of common topics and challenges within the regulatory landscape, we are recognized experts in the following fields:
- End-to-End Labeling, including process improvement and implementation, organization and governance design, end-to-end tracking technologies and deployment, system integration, content creation and maintenance (CCDS, PI, PIL, IFU, Artwork, etc.), and inspection readiness
- Managing Regulatory Data and Information in the context of RIM, IDMP, UDI and other regulatory and operational requirements, spanning both process and technology consulting
Engagements typically begin with a detailed current state assessment to identify and prioritize improvement opportunities, and continue beyond pragmatic recommendations to include detailed solution design and implementation. This includes managing the change, developing and revising controlled documents, incorporating revised responsibilities into organizational and role definitions, and developing training plans and materials for roll-out across functional stakeholders. Our unique ability to act as a bridge between business and IT is due to our in-depth understanding, hands-on experience, and engagements across business functions, IT, and technology vendors and service providers.
Our ability to speak the same language and work with our clients’ subject matter experts, who have deep institutional knowledge, enables us to provide improvements which are tailored to each organization, and are implemented smoothly and embedded to ensure benefits continue to be realized and sustained beyond the end of each project.