Clinical Research
Clinical trials have become increasingly complex to manage due to the need for deep domain expertise. Quality and integrity are top priorities for sponsors and regulators alike. Backed by years of clinical research expertise, Navitas Life Sciences delivers consulting-led full-service clinical offerings to ensure efficient and effective trials for sponsors. Navitas’ flexible and adaptable clinical operations and data management capabilities can be deployed cost effectively, anywhere around the world. We have supported over 550 clinical trials across 20 therapeutic areas, including multiple COVID-19 trials during the pandemic.
For details please visit https://www.navitaslifesciences.com/clinical-research-clinical-trials-cro
Generics Development
With over 90% of the prescriptions in the US market being fulfilled by generics companies, the competition in this space is growing exponentially. This makes it imperative for generics companies to be first-to-market, while adhering to stringent regulatory requirements, ensuring high quality outputs, and maintaining a cost advantage. Navitas Life Sciences has supported 1100+ bioavailability and bioequivalence (BABE) studies and developed over 280 bioanalytical methods to support generics manufacturers.
Read more at https://www.navitaslifesciences.com/generics-drug-development-cro
Data Sciences
Navitas Life Sciences is a functional service provider (FSP) that supplies teams of highly skilled Data Managers, Statistical Programmers and Biostatisticians to meet our client’s statistical programming needs. The experience level of our professional resources, coupled with a remote worker status, provides for an advanced, efficient and smart work model, resulting in significant cost savings to our clients.
For details please visit https://www.navitaslifesciences.com/clinical-data-services-fsp
Regulatory Affairs
In order to remain compliant and competitive, life sciences companies must implement holistic benefit-risk management, drive proactive compliance in a cost-constrained environment, manage enterprise-wide product data, maximize speed-to-market and approval success rates, ensure harmonized operations, and enhance commercial success through optimal product life cycle management. As experts, having hosted industry-wide Regulatory Information Management networks, and delivered more than 170,000 regulatory submissions, Navitas Life Sciences has the capabilities to deliver end-to-end lifecycle management across the entire value chain of the drug and device regulatory environment.
For details please visit https://www.navitaslifesciences.com/regulatory-affairs-services-cro
Pharmacovigilance/Safety
Amid increasing maturity and shifts in regulations globally, Life Sciences companies need to implement an effective pharmacovigilance (PV) system that satisfies requirements and mandates of regulators and markets alike. With a track record of defining and upholding PV compliance for multiple global Life Sciences companies, Navitas Life Sciences understands the future of drug safety and believes in transforming performance and compliance by improving processes. Navitas Life Sciences helps companies minimize risks across the product lifecycle, from development to post-marketing surveillance.
For details please visit https://www.navitaslifesciences.com/pharmacovigilance-patient-safety-pv-cro
