Have you received a deficiency letter from the FDA?
For many, this is the next step in the PMTA process. We can partner with you to deliver high-quality data that are required to process your application.
Hall Analytical is a contract research organization that has been working on PMTA projects for over two years. With ISO-17025 accredited methodologies, we are perfectly placed to support PMTA projects with the highest quality scientific data available. Quality underpins everything that we do.
Although independent, we work in partnership with leading toxicology and regulatory consultants in the interest of product security. This enables us to provide a complete end-to-end PMTA service. We also offer a full TPD notification solution.
Keep your ENDS franchise ahead of regulation and request a consultation today.
Following the wave of submissions prior to 9th September 2020, many companies are now likely to receive a deficiency letter from the FDA. Hall Analytical are well placed to support clients and provide them with the high-quality scientific data that the agency is looking for in ensuring that your product is appropriate for the protection of public health.
OUR RECOVERY SERVICE
Hall Analytical began work on their first PMTA project in 2018. Prior to the 9th September deadline for deemed products, we had tested on over 100 products that were subject to PMTA submissions. If you are getting ready to begin your next wave of submissions, it is vital that you chose a lab partner with a great deal of experience in this area.
Our recovery service involves:
We test for all HPHCs in both liquid and emissions. We also provide long-term stability studies to define your product shelf life.
EXTRACTABLES & LEACHABLES
Our 20 years of experience in working on E&L studies offers unrivalled experience to our customers.
We support bridging study strategies, allowing us to compare your product against others.
4 PHASE APPROACH
PHASE 1: ENGAGEMENT & STRATEGY
This is the initial engagement and establishment of client requirements. A briefing document will be generated to support engagement with the FDA, to avoid the risk of non-compliance.
A preliminary screen for potential toxicants is conducted to informally evaluate the potential for the products’ compliance with PMTA.
A high-level review of ingredient toxicology is performed to highlight any compounds of concern.
PHASE 2: SCIENTIFIC STUDIES
In this phase of development, new data pertinent to the product[s] are generated. These data may include customer perceptions, evaluation of the risk of misuse or gateway use, the topography of the product[s], data on HPHCs.
Full stability study = 12 months
PHASE 3: EXTENSIVE LITERATURE REVIEW
Phase 3 involves an extensive review of publicly available data and scientific research pertinent to the product[s].
The intention is to draw extensively on publicly available data in place of the generation of new data which is costly, timely, and increases the risk to the overall project.
A review of the manufacturing process also takes place with appropriate validation performed where needed and supported by scientific studies.
PHASE 4: FINAL REVIEW AND SUBMISSION
The sum of scientific data is reviewed, drawing the final conclusion on product safety and public health benefit—a key element of PMTA is that the product is to be beneficial to public health.
Comparisons are made against comparator products and the body of scientific data related to the product is drawn on extensively.