Clinical Trial Applications, CTA Submissions, CTA Regulatory Submission

Clinical Trial Applications (CTAs)

Clinical Trial Applications (CTAs) - Overview

To obtain clinical trial authorization, Clinical Trial Applications (CTAs) must be submitted with all the required documentation as per the Health Authority (HA) requirements. Once submitted, the CTA shall be reviewed by the respective HA. Upon satisfactory review and evaluation of the information submitted in the clinical trial applications, the sponsor will receive formal authorization from the HAs to conduct the proposed clinical trials.

Clinical trial regulations and safety reporting requirements vary from one country to another. In the United States Food and Drug Administration (US FDA), CTAs are submitted in the form of Investigational New Drug Applications (INDAs), whereas for the Medicines and Healthcare Products Regulatory Agency (MHRA in the UK), and the EU member states, such requirements include the submission of an Investigational Medicinal Product Dossier (IMPD) along with the clinical trial authorization application. For Canada and most other countries, a clinical trial authorization application is commonly referred to as Clinical Trial Application.

Clinical Trial Applications (CTAs) - Freyr Expertise

Regulatory response strategy, preparation, and on-time submission of responses to Health Authority (HA) queries pertaining to CTA submissions.
Preparation and submission of CTA amendments (CMC & clinical) and annual reports (wherever applicable).
Authoring CTA dossiers, technical reviews, and submission of CTAs for pharmaceutical products, vaccines, biosimilars, and other biological products for most countries.
Strategic support in identifying the optimal Regulatory approach for CTA submissions and obtaining CTA approvals in multiple countries across the globe (US, EU, LATAM, MENA, Africa, APAC, etc.).
Gap analysis of developmental data/submission data against the current Regulatory requirements of different countries for CTA submissions and expert advice on mitigation plans for the identified Regulatory issues, submission risks, potential clinical hold issues, etc.
Follow-up with the Regulatory agencies (MHRA, European Medicines Agency (EMA), US FDA, Health Canada. etc.) throughout the CTA filing process.
Tailored support in clinical trial data management and CTA Regulatory submission.

What Our Clients Say?

It is good for submission. And I understand today is a holiday, so I have to thank Freyr team for doing this. FDA called us and is trying to close out the CBE-30 filed in March and wanted these documents as soon as possible. So, I truly appreciate your assistance, even on a day off.

President

An Innovative Pharmaceutical Company

This project, eCTD DMF conversion, was against a very tight schedule and required dedicated resources. Freyr provided the dedicated resources needed to meet our immediate Regulatory filing requirements. Freyr was always on schedule/or exceeded the dates outlined in the project plan. All changes were handled within 24 hours and notifications of changes were promptly provided. This project is not yet complete but has been very successful at this point.

Quality Control and Regulatory Manager

USA-based Pharmaceutical company

The ANDA receipt is received! Thank you very much for your hard work, patience and support for our work over the last couple of months. We are delighted that we were able to meet the timeline and hit an important corporate goal of our young company. Thank you again and look forward to working with your team on the next project!

Research and Technology based US pharmaceutical company

Excellent! Congratulations to the team for this accomplishment! Thank you everyone for your hard work on this. In addition, please let us know what is needed for the submission of the Type III DMF to Health Canada. I assume we will need to update some of the initial administrative documents, but most of the content is identical to the Type IV DMF.

Senior Research Assistant,

US based leading biopharmaceutical company

We have crossed two important milestones in two days, thanks in a large measure to all of you. We are a small company, a small set of people with big dreams. And given the industry we are in and how we operate, it is possible to realize our dreams only with the help of partners like you - who share our beliefs and push hard with their own collective might. On behalf of our organization, I would like to thank you for your competence and commitment in delivering ANDA files. Kudos to the whole team.

Operations Head,

A Privately Held Pharmaceutical Research and Development Company

Thank You Freyr team for a Fantastic 2019! The OTCDOCS TD user community feels better supported despite the technical challenges and system constraints. Thank You for being the voice to represent their ways of working and helping us design a more user friendly, effective system going forward.

System Owner,

UK multinational pharmaceutical company

Great job with your impact and for noticing that there was an error on the insert SAP code. This shows great attention to detail as well as expertise in all the other point areas that you are thoroughly investigating, regarding the QA database etc.

Graphics Manager | Global Regulatory Affairs,

Canada based, global pharmaceutical company

Clinical Trial Applications (CTAs)

Clinical Trial Applications (CTAs) - Overview

Clinical Trial Applications (CTAs) - Freyr Expertise

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