Clinical Trial Application (CTA) Submissions

Freyr facilitates global clinical trial success by expertly guiding sponsors through the complex process of planning, preparing, and submitting Clinical Trial Applications (CTAs) for diverse medicinal products, ensuring compliance with country-specific regulations.

Clinical Trial Application (CTA) Submissions - Overview

A Clinical Trial Application (CTA) is a Regulatory dossier that is submitted to the Health Authority (HA) of the country in which a sponsor would like to conduct clinical trials with Investigational Medicinal Products (IMPs) or with approved drugs to explore new indications. To obtain clinical trial authorization, a CTA application must be submitted with all the required documentation per the regulations of the competent HA. The regulations and safety reporting requirements for clinical trials vary from one country to another.

In the case of the US FDA, a Clinical Trial Application (CTA) is submitted in the form of an Investigational New Drug (IND) application, whereas for MHRA (UK) and the EU Member States, such requirements include the submission of the Investigational Medicinal Product Dossier (IMPD) along with the Clinical Trial Authorization application. In Canada and most of the world countries, a clinical trial authorization application is commonly referred to as a Clinical Trial Application (CTA).

In general, a Clinical Trial Application (CTA) contains information on the quality, safety, and efficacy (or proposed therapeutic uses) of the investigational drug. The Chemistry, Manufacturing, and Controls (CMC) and safety/efficacy data requirements will vary based on the phase of the clinical trial conducted (i.e., Phase I, Phase II, and Phase III). Once submitted, the CTA shall be reviewed by the respective HA. Upon satisfactory review and evaluation of the information submitted in a CTA, the sponsor will receive formal authorization from HAs to conduct the proposed clinical trials. The Regulatory requirements for different phases of clinical trials and the type of study population are divergent in different countries of the world.

The general challenges in conducting clinical trials are planning clinical trials, CTA/IMPD/IND application preparation, and submission as per country-specific regulations. In the case of global clinical trials (trials in multiple countries), integration of the Regulatory process (CTA submission in multiple countries) with clinical material manufacturing/supply logistics & engagement with clinical trial sites is crucial and requires prior experience and thorough knowledge of CTA filing process in each country.

Moreover, the right Clinical Trial Management System (CTMS) with Clinical Data Management Systems (CDMS) is essential to effectively conduct clinical trials and for clinical data management from multiple trials/sites.

Freyr assists sponsors in the planning, preparation, and submission of CTA in different countries for varied types of medicinal products such as small molecules, recombinant protein products, vaccines, cellular and gene therapy products, etc.

Clinical Trial Application (CTA) Submissions

  • 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/submission data against the current Regulatory requirements of different countries for CTA submission and expert advice on mitigation plans for identified Regulatory issues, submission risks, potential clinical hold issues, etc.
  • Authoring, technical review, and submission of clinical trial applications for pharmaceutical products, vaccines, biosimilars, and other biological products for most countries.
  • Preparation and submission of CTA amendments (CMC & clinical) and annual reports (wherever applicable).
  • Regulatory response strategy, preparation, and on-time submission of responses to HA queries on CTA submissions.
  • Follow-up with Regulatory agencies throughout the clinical trial process.
  • Support in preparing the CTA dossier.
  • Regulatory support in CTA filing.
  • Submission of Clinical Study Applications.
  • CTA Regulatory submission.
  • Filing the IND application.
  • Offering CTA guidance.

Celebrating Customers Success

 

Medicinal Products

Regulatory Affairs

India

Thank you for the timely support over the weekend, which allowed us to resubmit quickly after being notified. This continuously demonstrates Freyr's commitment towards our company’s milestones.

Director - Global Regulatory Affairs – Operations

India-based, Global Top Generic Pharma Company

 

Medicinal Products

Publishing

UK

I am sure you have heard by now that we have received our first-ever approval from the FDA for our Brands division. This is a major milestone for us as well as for my team here in Reg Ops. I would be remiss if I didn’t point out that we would not have been able to do this without the help of your dedicated team. From the original filing, then the following year of responses, all helped get us to final approval.

Thank you Freyr team for a job well done!

Sr. Director, Head of Regulatory Operations

Ireland-based, Global Specialty Pharmaceutical Company

 

Medicinal Products

Regulatory Affairs

USA

Please relate to the team the excellent job they have done on the IND reactivation. Specifically, the high-quality module 3, written by Freyr. It was very comprehensive, very few revisions were required, and we had no questions from Health Canada or FDA. No CMC questions: that was a first for me. So very responsive to my many requests, which I am sure can be frustrating but always helpful while producing excellent work.

Thank you for always being available and responding quickly and comprehensively to all my requests.

What a great team you have, Freyr.

Lynne McGrath

Regulatory Consultant

 

Medicinal Products

Regulatory Affairs

USA

Congratulations!!! ​

Thanks for your great support for a successful ANDA filing, especially to the publishing team. Heartfully appreciate their last hours of hard work.

Assistant Manager​

US-based, Leading, Complex Generic Pharmaceutical Products Company​

 

Medicinal Products

Regulatory Affairs

USA

Thank you all for the great support!​

CEO

US-based, Leading Innovative Pharmaceuticals Company​

 

Medicinal Products

Regulatory Affairs

USA

The ANDA receipt has been 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 we look forward to working with your team on the next project!

Senior Director of Business and Product Development​

US-based, Leading Innovator Pharmaceuticals Company​