ONIX

ONIX offers eCTD Submission Services to the pharmaceutical industry. We assist Life Science companies with their regulatory submission activities to the Health Authorities. Our clients are based globally and vary from large pharmaceutical companies/CROs to independent consultants.

ONIX consultants are highly experienced and understand the complexity of the changing global electronic regulatory requirements. We pride ourselves on delivering eCTD submissions efficiently and on-time. Our personable and friendly approach ensures to make the process of eCTD Submissions easy. With Onix‘s years of experience we are well positioned to advise your company on Best Practices for a successful submission.

ONIX Services are flexible and can be tailored to ensure your eSubmission requirements are met cost-effectively, saving your company valuable resources and time.

The key to every successful eCTD submission is in how we offer our services, from strategy to submission your project is in safe hands. Our core values are:

Simplicity

We are excellent at making the process simple and accessible for our clients

Accuracy

We consistently deliver accurate  and technically validated submissions

Fast

Our service is fast and conducted in a very personable way

Expertise

Our solid foundation of global expertise is driven by world-wide collaborations with companies and regulatory agencies