Regulatory Compliance and Submissions: Navigating Regulatory Pathways

Regulatory involves authoring, compiling, and checking regulatory submissions and interacting directly with staff at regulatory bodies in line with the overall PhoenixTMG strategy.

Regulatory submissions for a clinical study will typically involve submitting documentation and data to a regulatory authority for review. This submission will generally include an application (Feasibility Questionnaire and CDA) for authorization, or it may be in response to a specific question raised during the review of the feasibility questionnaire process.

The outcome of the submission will determine whether or not a site can move beyond clinical trials into the Sponsor agreements.

The complexities of regulatory submission processes have long posed a challenge for smaller or emerging clinical sites and – more so recently. Submission requirements have become increasingly strict with applications requiring a significant amount of documentation and data.

There are a few common types of regulatory submissions. These include:
  • Clinical trial applications (INDs, CTAs)
  • PhoenixTMG Information Amendments
  • Marketing applications
  • Applications for modifications of submissions
  • Availing contract services
  • Responses to agency inquiries during the review
  • Post-approval commitment submissions

How we work

Initial Assessment

We begin by conducting an in-depth analysis of your trial’s regulatory needs. This includes evaluating the trial’s objectives, therapeutic area, target markets, and specific regulatory requirements.

Tailored Strategy

Based on our assessment, we develop a customized regulatory strategy that aligns with your trial’s goals. This strategy serves as a roadmap for the entire regulatory process.

Document Preparation

Our expert team takes care of all documentation and submission preparation, leaving you with more time to focus on your research and development efforts.

Regulatory Submissions

We submit all required documents to the relevant regulatory authorities, following their guidelines and timelines meticulously.

Continous Support

Throughout the trial, we provide ongoing support, addressing any regulatory challenges that may arise, and ensuring compliance is maintained.

Submissions may be made electronically, in hard copy, or both, though agencies are increasingly encouraging the use our application format. The level of detail and amount of information required varies according to the type of submission, but in every case, comprehensive, accurate submissions maximize the likelihood of a favorable regulatory review.