We can be your strategic partner for your Pre-Market application submission (PMTA) process.
Your product is unique, your data is unique and your story should also be unique. Through our network of in-house and external consultants with deep industry experience and portfolio of client services, we can help you navigate the PMTA maze and ensure that your product moves from concept, through prototype all the way to regulatory submission. With our track record, experience, and comprehensive client services all backed by strong and professional project management, we can offer our clients a total solution to ensure that their product gains marketing authorization with FDA efficiently and smoothly.
US Premarket Tobacco Product Application (PMTA)
Strategy Definition
This stage involves the extensive compilation of scientific data. Your dedicated Project Manager will manage the full PMTA process on your behalf, liaising with experienced Workstream Leads in each of the 4 key compliance areas. Alternatively, companies with internal Workstream Leads can supplement their in-house capabilities with a tailored solution.
Manufacturing
Full disclosure of manufacturing sites and their control processes.
Product Formulation Analysis
Scientific product analysis and Chemistry Manufacturing and Controls "CMC" evaluation.
Health Investigation Non-clinical Studies
Detailed assessment of the toxicological and pharmacological profile of your products.
Health Investigation Human Subject Studies
Clinical studies undertaken with your specific products, in order to determine their potential impact on public health.
Studies undertaken in the 4 key compliance areas are highly inter-related - so timing and co-ordination of activities is critical to maximize synergies across the studies.
Other Services
[ IMPORT ]
Our company has a Tobacco import license by TTB US Department of the Treasury. We serve to import your products to the United States of your tobacco products.
FDA
[ FDA APPLICATIONS]
Prior to the first shipment of tobacco products to the United States, FDA US Food and Drug Administration requires approval for products.
[ WAREHOUSE ]
Before the transfer of the imported products to your customers, we offer storage services in our warehouse which is approved by TTB.
[ LOGISTICS ]
We provide shipment service for your products in our warehouse or US customs. Please contact us for detailed information on Tobacco products logistics to the United States.
[ SALES ]
We provide services for the importation of imported products to the American market.
[ MARKETING ]
These services include: regional dealership agreements, dealer visits, order tracking, exibition attendance support, online web sales support.