Resources - Navitas Life Sciences

Resources

Moving Ahead with Intelligent Virtual Clinical Trials

Implementing a Regulatory Technology Solution to support DMS, eCTD, and SPL needs

Partnering to deliver End-to-End Labeling Services to support Labeling and Artwork Management

A collaborative partnership providing resources for Regulatory Affairs Technical and Publishing

Maintaining Continuity of Clinical Research in the Era of COVID-19

India can Reshape Hybrid Clinical Trials

Highly Efficient Safety and Efficacy Evaluation of COVID-19 Therapies in Moderate to Severe Patients

Optimized Safety and Efficacy Clinical Trials for a Combination Therapy on Moderate COVID-19 Patients

Enhancing the overall efficiency of global Regulatory Information Management

Providing Regulatory Affairs support to manage Life Cycle Maintenance Submissions for a mid-sized biopharma

Regulations to enable safe, effective, & high-quality AI, ML & Digital Solutions in Drug Development

Driving accelerated compliance and delivering First-Time-Right Submissions with pharma READY

Delivering Publishing and Submission Management Services for a mid-sized global biotechnology company

Achieving End-to-End PV Operations through Integrated Processes, Technology and Services

Delivering an End-to-End Regulatory Technology Solution that provides One Source of Truth

Operational approaches to evaluate the safety & efficacy of therapies in moderate to severe COVID-19 patients

R Programming in Clinical Trial Data Analysis

Disrupting the Clinical Research industry by merging trial software development and trial delivery

QMS implementation on TrackWise Digital for the US operations of a top 10 pharma company in India

Enabling process excellence for Quality Management and Regulatory Affairs Operations with TrackWise

Clinical Trials viewed through a Manufacturing Lens

A Comprehensive QMS implementation on TrackWise for a top 10 pharma company in India

Strategic approaches to mitigate and manage non COVID-19 Clinical Trials during a Pandemic

Be compliant with DSCSA VRS Requirements with Navitas Life Sciences’ traceREADY

Delivering cost effective End-to-End Pharmacovigilance Services from Clinical Trials to Post-Marketing

Delivering Integrated PV Services and Technology to ensure Compliance

Reducing costs, increasing efficiency and compliance while improving Patient Safety

Can Pharmacovigilance meet the COVID-19 Challenge? A checklist approach to PV Business Continuity

Enhancing the overall efficiency of global Regulatory Information Management

Managing the Operational Challenges of COVID-19 Clinical Trials

Are you prepared for the new EU Medical Device Regulation (MDR) requirements?

Leveraging AI Based Platform and Analytics to Drive Successful Clinical Trials Outcomes

RIM Maturity: A Strategic Path to RIM Excellence A multi-dimension tool for building RIM Strategy

Transform your End-to-End Safety Operations for greater visibility and control by leveraging leading edge tec

Barriers Preventing Clinical Trial Software Development

Automation, Analytics and Artificial Intelligence (AI) – A Roadmap to NextGen Pharmacovigilance (PV) Transf

Leveraging Technology for Improved Outcomes across End-to-End Labeling

The next safety database upgrade – assessing impacts of E2b(R3)

ICH E6(R2) Readiness Assessment Framework helps you ensure compliance and transform your clinical operations

RIM Maturity Model: A strategic path to next-generation Regulatory Information Management

EudraVigilance - Handling the far reaching and diverse impact on changes to EV system

Navitas Life Sciences On-Demand Webinar Clinical & Regulatory Data Convergence: Increasing Enterprise Value

The building blocks of successful outcomes in Data-Driven Clinical Trials

Regulatory Information Management Just how far have we progressed?

The safety database in a pharma company – tactical considerations for delivering on compliance and efficien

Integrated Clinical Data Services, Clinical Data Management, Biostatistics and Medical Writing

E2E labeling – Achieving Global Consistency

Digitally transformed pharmacovigilance Why we need it and why it will take a while to become reality

CDISC SDTM Conversion, a Case Study in Perfection

PV Organisations Reimagined - Roadmap to transforming into a strategic PV organisation

Organizing your Global Labeling Function – what is the optimal structure?

PSP Management

The Challenge of Regulatory Information Management

Biostatistics and Statistical Programming - Partnering to accelerate success in clinical submissions

RIM Maturity Pathway – achieving your RIM goals using the RIM Maturity Model

Succeeding with Revised GVP Module IX: Seizing the Opportunity and Managing the Challenges

Clinical Data Management Flexible Clinical Data Services Enables a Successful IND Submission

Medical Writing

PV Safety Benefit Risk Management Optimisation and Integration

Is labeling the next area ripe for outsourcing?

Getting Inspection Ready

Data Standardization Achieving Successful Submissions while Overcoming Complexity

Will you be ready to comply with DSCSA Verified Router Services

Navitas Life Sciences On-Demand Webinar EU FMD Compliance: Are You READY?

Labeling Organization – Simplicity or Specialism?

WhitePaper - Preparing for successful IDMP submission – an opportunity to gain real business benefit and be

PV Affiliates Risk Assessment

End-to-End Labeling Tracking Tools in Action

Risk Minimisation Through the Affiliate Lens

Discovering Value with Terminated Drugs and Studies

Building a Regulatory Information Enterprise Architecture

GVP Module IX update – Impact beyond borders

Webinar series on ICH E6 GCP compliance Introducing ICH compliant RBM to your Clinical Trials Webinar

End-to-End Labeling through an Optimized Process and Technology Implementation

Client Case Study - End-to-End (E2E) Labeling

Implementing TrackWise Quality Management Systems and Document Management for Global Excellence

Client Case Study - End-to-End (E2E) Labeling

A Regulatory Outsourcing Partnership for Submission Management, Publishing and Product License Support

A unique view of sustainable IDMP solutions

Case Study - Overhauling Pharmacovigilance Processes, Governance, and Technology

Case Study - End To End PV Optimization

Ensuring SDEA Oversight and Harmonization in an M&A Context

WhitePaper - The Case for Streamlined Consulting Complaints Management in Medical Devices

Diabetes Infographic and the 14 Treatments that will Come Off Patent by 2025

Respiratory Diseases and their Treatments that will Soon Come Off Patent

Inhalation Studies

EU FMD Compliance Made Easy with traceREADY EU FMD Compliance Made Easy with trace READY

Transform Your Safety Operations With Our End-to-End Pharmacovigilance (PV) Services

Successfully rescuing an Oncology Phase III trial for a global biopharmaceutical company

Clinical Data Services

Driving successful outcomes for Clinical Trials by providing trial oversight and near-realtime insights

Regulatory Services

Accelerators for faster and better implementations of Argus Safety

Simplify and strengthen your End-to-End labeling process with Labeling Assessment Express ™

End-to-End Bioavailability & Bioequivalence Services Enabling the First-to-Market Advantage

Methods Library

Euglycemic Clamp Studies

Clinical GCP Rapid Assessment

Clinical Data Management

Data Standardization

Biostatistics & Statistical Programming

Non Interventional Studies

pharma READY – Product Suite to ensure robust process optimization for First-Time-Right Submissions

Navitas' Offering of Oracle Argus on cloud based multi-tenant platform

Pathways for successful UDI implementation

Drug meets Device Successfully integrating Combination Products and Medical Devices into a pharmaceutica

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