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) - Expertise
- Regulatory response strategy, preparation, and on-time submission of responses to Health Authority (HA) queries pertaining to CTA submissions.
- Authoring CTA dossiers, technical reviews, and submission of CTAs for pharmaceutical products, vaccines, biosimilars, and other biological products for most countries.
- 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.
- Preparation and submission of CTA amendments (CMC & clinical) and annual reports (wherever applicable).
- 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.).
- 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.
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