For more than 20 years, Clinlogix has led regulatory initiatives for companies entering new frontiers of medicine. Our vast, global regulatory affairs experience is particularly valuable in today’s development landscape as pharmaceuticals, medical devices, and diagnostics converge toward a future of precision medicine.
In an ever-changing regulatory environment, your novel product may face uncharted territory, especially when your research program encompasses numerous countries worldwide. From initial strategy to final submission, Clinlogix provides up-to-date global and local knowledge of these regulatory pathways. This is backed by experts who have worked with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for decades. We collaborate closely with local, state, and federal regulatory agencies to help refine best practices and harmonize regulations.
Because we have local teams in place, we understand location-specific regulations, guidelines, and standards for product development. Not only will we develop and execute an efficient regulatory compliance strategy, but we also ensure your regulatory and compliance risk mitigation strategies are robust.
- Global clinical regulatory strategy and planning to choose appropriate and economically viable pathways
- Project management to orchestrate design documents, clinical study documents, study authorization submissions, statistical analysis, safety reporting, report writing, and more
- Post-market surveillance and proactive planning to continuously gather clinical economic data
- Vigilance and reporting
- Quality assurance and control, including process optimization, SOP development, staff training, and internal auditing
“I would like to thank each one of you for your meaningful role in our clinical study thus far. The 510k clearance would not have happened without Clinlogix’s contribution throughout the study and especially toward the data base lock and finalization of the CSR. Your dedication and good cooperation helped us to meet our goal on time.” – Clinical and Regulatory Specialist, Medical Device Company
“Thank you for all you do to make our projects run so smoothly. You are always a joy to work with!” – Clinical Trial Coordinator, Medical Device Company