To obtain a clinical trial authorization, a Clinical Trial Application (CTA) 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 CTA, the sponsor will receive a 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 case of the US FDA, CTAs are submitted in the form of Investigational New Drug Applications (INDAs), whereas for MHRA (UK) and the EU Member States, such requirements include submission of Investigational Medicinal Product Dossier (IMPD) along with the clinical trial authorization application. For Canada and most of the world countries, clinical trial authorization application is commonly referred as Clinical Trial Application.
- Regulatory response strategy, preparation, and on-time submission of response to Health Authority (HA) queries pertaining to CTA submissions.
- Preparation and submission of CTA amendments (CMC & Clinical) and Annual reports (wherever applicable).
- Authoring, technical review, and submission of CTAs for pharmaceutical products, vaccines, biosimilars, and other biological products for most of the world 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 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.
- Follow-up with Regulatory Agencies (MHRA, EMA, USFDA, Health Canada. etc.) throughout the clinical trial process.