Biologics &
Biosimilars
Get the competitive edge for your biological product
We help bring your Biologicals to market quickly and effectively
Experts at handling complexity in biologics and biosimilar studies
Proven expertise in Biosimilar and Biologics

Extensive clinical experience and proven trial management

Ability to design lean protocols for market approval

Effective cost-efficient management of trials

Excellent track record for meeting regulatory requirements
Oncology Phase III Biosimilar Study
Rescue of P3 trial from regulatory risk
At Navitas, we understand the complexities of biosimilar studies and deliver results to exceed your expectations

100% on-time completion of key milestones

Record recruitment completion within timelines

Good Patient retention with Minimal 10% dropout
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Navitas Life Sciences
is named as a Major Contender
in Everest Group’s
Clinical Development Platforms Products
PEAK Matrix® Assessment 2022
Navitas Life Sciences is your perfect partner for all your biologics and biosimilar study Needs
Building Blocks for successful Biologics and Biosimilar Studies
Biologics and Biosimilars have similar design, but they differ in several ways. We understand the nuances of these two types of drugs, which is why we are pioneers in this field.
Type of Drug | Biologics | Biosimilar |
---|---|---|
Study | Therapeutic, novel drug development Phase 1- Phase 3 efficacy and safety studies | Pharmacokinetic comparative study Phase 3 efficacy and safety studies |
Time to market | 8-15 years | 7-8 years |
Cost | 1.2 billion$ | 100-375 million $ |
Post authorization studies | Phase IV and pharmacovigilance | Phase IV and pharmacovigilance |
Patent | Patentable | Non-Patentable |
Gain the Competitive Edge for your Biosimilar Product with Navitas Life Sciences
- Inspection ready facilities
- Ready volunteer access
- State of the art technology
- Advanced data management capabilities
- Multidisciplinary capabilities
Inspection ready facilities
Ready volunteer access
State of the art technology
Advanced data management capabilities
We have FDA 21 CFR Part 11 compliant computer systems for sample and data analyses. Our Quality Management System is ISO 9001 certified. Our data management system includes Computer system validation.
Multidisciplinary capabilities
Leveraging the Efficiency of AI &ML in Building Efficient Studies
All our clinical trials are backed by OneClinical, our AI&ML driven platform that offers you near real time data visibility and analytics in an outcomes-based engagement model. With OneClinical, you can make informed decisions and take proactive action to maximize the success of your clinical trial.
OneClinical Delivers Better Outcomes for You
Save Time
We have the technical expertise to drive standardization and near real time monitoring to lower cycle times
Time for Complex Study Mapping
Cycle Time to Develop Initial Interface for Data Warehouse
Overall Cycle Time
cost to develop initial Interface for data warehouse
field monitoring costs through Triggers, Reduced SDV
cost of clinical monitoring
Reduce Cost
We can drive and deliver significant reduction in total cost through people, process and technology capabilities