US FDA Center for Tobacco Products Submissions
The Family Smoking Prevention and Tobacco Control Act gives the US FDA’s Center for Tobacco Products (CTP) broad authority to regulate tobacco products. In addition to requiring that a number of warning label statements appear on tobacco packaging, certain products must now be submitted for premarket approval and go through a regulatory process similar to pharmaceuticals.
Synchrogenix offers an end-to-end solution to companies seeking regulatory approval for “reduced risk” claims, premarket review, and nicotine replacement therapy.
Consulting, Authoring and Submission Services
Synchrogenix has extensive experience in planning and preparing all aspects of regulatory submissions to the US FDA, as well as the unique advantage of integrating best practices based on previous success with Premarket Tobacco Applications (PMTAs) and Modified Risk Tobacco Product Applications (MRTPAs).
Project Scope and Content Planning
At the onset of our engagement, we will align on your current state and marketing goals across all platforms and products. Our teams will work closely to determine the size and effort needed to generate the submission(s) to meet target dates. Based on the scope, a comprehensive plan, governance structure, and delivery milestones are established to allow for work to be processed incrementally as documents are finalized.
Regulatory Strategy and Operational Consulting
Regulatory strategy and operational consulting are key elements to ensure the successful outcome of interactions with CTP. Regulatory strategy consulting includes both interactions with CTP seeking alignment in approach for PMTAs as well as interpretation of US FDA guidance documents and regulations to ensure project approach is both comprehensively and adequately aligned with what is needed in order to obtain a successful CTP review outcome.
Regulatory operational consulting provides guidance and practices around assembly and logistics of the filing, i.e., determining a logical structure for organizing content and verifying that electronic navigation is both adequate and accurate.
Synchrogenix has also served in an advisory capacity on behalf of our clients in multiple meetings with CTP, including:
- Pre-submission meetings focused on content and preparation efforts and seeking consensus in approach
- Post-submission meetings to provide responses to reviewer questions that arise during the course of review
- Consultative services to prepare materials in advance of meetings with CTP involving only sponsor and Agency
All engagements are structured to include a Submission Lead, Submission Coordinator, and Publishing Lead. Our team is staffed with experienced professionals who will provide continuity and a clear point of contact throughout the engagement. The team is responsible for deliverables and oversight throughout the course of a submission project including:
- Project management of the entire project
- Regular communication and project status
- Resource allocation and management for all publishers involved
- Build and update the Submission Tracker that will identify each component and track status at a file level
- Build and update the issues log to track issues through to resolution at the file level
- Track overall project risks and issues and then communicate those risks and issues in monthly status reports
- Review all submission components for PMTA/MRTPA readiness
- Deficiency reporting on PMTA/MRTPA related issues
- Act as technical contact to CTP for submission related inquiries
- Obtain application number from FDA (if necessary)
- Submission Transmission via FDA Electronic Submissions Gateway (ESG)
Our team of over 225 experts includes writers who have direct experience preparing PMTAs and MRTPAs in their entirety including, clinical; nonclinical; chemistry, manufacturing, and controls (CMC); and safety components.
Includes formatting documents in native Microsoft Office applications, as well as rendering these documents to PDF and then publishing them according to well-established electronic submissions standards dictated by the US FDA.
To aid in the process of generating “submission ready” documents, Synchrogenix offers authoring templates and a document style guide. We are also able to offer standards documents, such as an Authoring Style Guide and training resources to provide the authoring team a consistent set of standards for authoring documents should the applicant elect to format documents internally with a cross-functional team of SMEs.
Publication of Submission Documents
The organization and publishing of submission documents including defining a set folder structure, file names and utilization of hyperlinked indices to aid in navigation. Files are published in accordance with documented, well-established and accepted standards for electronic submissions to the FDA.
Clients routinely inquire about converting existing datasets to Clinical Data Interchange Standards Consortium (CDISC) format, or generating new datasets in CDISC format. In response, we have created CDISC compliant datasets and generated define files according to CDISC data standards for non-clinical and adult human studies.