ONIX eCTD PUBLISHING SERVICES

Simplifying complex Regulatory Operations

We are a boutique consultancy specialising in regulatory operations services to support our clients with drug applications to the health authorities for approval and drug to market. We measure our performance by our client’s success.

Our wealth of experience in global eCTD submissions and eCTD publishing services allows us to work closely with our clients and navigate them through the regulatory landscape effectively. We are committed to providing the best service to our clients and are proud of our track record of success. We would be delighted to work with you if you are looking for help with your regulatory operations.

eCTD Submissions Management Services

Regulatory submission management can be a complex process, we manage the complex and make it simple. We wholly manage the eCTD process, from start to finish, maintaining a complete overview of the submission across multiple lifecycle stages and to global regulatory health authorities.
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Regulatory Advisory Services

Our team is on hand to provide best practice advice to ensure our clients are set up for success with the submission and ongoing lifecycle maintenance.

We optimise, improve and reform processes to ensure our clients are well positioned and informed in the current regulatory landscape.

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Word formatting and PDF publishing

Correctly formatted MS Word files for eCTD submissions can be challenge, we are technical experts at MS Word formatting. 

We format the files ready for PDF conversion and onto PDF publishing. The PDF publishing specification is followed to meet the high quality standard set by the ICH and regional regulatory authority guidelines.

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eCTD Template Automation

Drive efficiency with predefined CTD Word templates to support a seamless and simple submission journey. The automated CTD word templates remove the uncertainty in formatting, so our clients can focus on content.
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Regulatory Affairs Services​

Beyond Submission Management ONIX have built a network of trusted consultants and CROs to provide value across Regulatory Affairs – Writing and Management, CMC, Clinical and Non-Clinical.
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