Pre-Approval Regulatory Services
Navigating the complex Regulatory landscape with expertise and precision
In the fast-evolving world of clinical development, securing IND/NDA approvals is fraught with challenges. At Navitas Life Sciences, we have a proven track record of guiding sponsors through the intricate regulatory landscape, ensuring successful management of clinical phases. Our expertise addresses the critical challenges faced by the industry, which can often be bottlenecks to clinical trial approvals.
Key challenges we address include:
Lack of Regulatory Strategist or Regulatory Affairs Team
Need quick access to top-tier regulatory experts
Complex FDA Queries
Struggling with intricate US FDA questions? We provide the clarity you need
Ethics Committee Queries
Expertise in addressing and resolving ethics committee concerns
Cost Reduction and Resource Management
Strategies to cut operational costs and handle resource turnover efficiently
Strategic Approval Acceleration
Developing the right strategy for expedited approvals
Best Practices for Accelerated Approvals
Implementing industry best practices for faster approval processes
Technology Integration
Offering single-platform solutions to unify multiple technology systems
Comprehensive Regulatory Services
At Navitas Life Sciences, we excel in managing pre-IND/CTA/IMPD, and post-IND findings, guiding you seamlessly from Phase I through Phase III trials across the US, EU, CA, and RoW markets. Our services include:
Medical and Safety Writing
- Toxicology, Clinical, and Non-Clinical Sections : Expert evaluation and writing.
- Protocol Writing and Review : Crafting and refining study protocols.
- Safety Reports Preparation : Detailed DSUR and SUSAR reporting.
End-to-End Regulatory Solutions - Health Authority Interactions
- FDA Query Responses and Safety Updates : Precise handling of FDA queries.
- Sponsor/Health Authority Meetings : Expert negotiation and communication.
End-to-End Regulatory Solutions - CMC Management
- Regulatory Submission Preparation : Thorough scientific reviews and CMC authoring.
- Health Authority Responses : Expert preparation and response management.
End-to-End Regulatory Solutions - Publishing and Submission Management
- Clinical Study Report Publishing : Comprehensive publishing services.
- Submission Planning and Life Cycle Management : Effective management from planning to submission.
- Dossier Compilation : Utilizing our pharmaREADY® Publishing Tool for seamless dossier compilation.
End-to-End Regulatory Solutions - Regulatory Strategy
- Regulatory Focus : Conducting gap analyses and accelerating the approval process.
- Global Submission Strategy : Providing due diligence, clinical strategies, and ensuring compliance with GLP/cGMP/GCP standards.
- Process Design and Implementation : Streamlining regulatory processes.
Project Management and Infrastructure
- Pre-IND Planning : Minimizing approval timelines through strategic planning.
- Project Delivery and Timeline Management : Ensuring projects stay on track.
- Client Communication : Maintaining clear and consistent communication.
- Project Governance : Regular meetings and progress tracking.
- Risk Management : Identifying, escalating, and mitigating risks effectively.
- Tool Deployment : Using tools like pharmaREADY® Document Management System, rimREADY®, and pharmaREADY® Publishing Tool for comprehensive regulatory submission management.
CASE STUDY
Providing end-to-end IND Regulatory and Medical Writing Services
With a predefined, and a very short submission window, learn how we provided end-to-end IND Regulatory and Medical Writing Services to secure approval for a Phase I study to proceed
Gain the Navitas Life Sciences Edge
Regulatory Strategists
Project Managers
Regulatory Operations Specialists (CMC, Labeling, and Publishing)
Medical Writing Specialists
BLOGS
Medical Writing Services CRO
Read our blog to learn about our comprehensive medical writing services tailored to diverse therapeutic areas to meet your clinical and regulatory needs
Overcoming challenges for a complex NDA for a Pneumococcal Conjugatae Vaccine
Learn how we provided support for a high priority New Drug Application (NDA) submission