Analytical Testing to Support Regulatory Packages
Regulations
Enthalpy specializes in analytical testing to support regulatory packages for submission. Enthalpy’s analytical and toxicology testing services fulfill requirements of:
- Health Canada
- FDA PMTA (Premarket Tobacco Product Applications) and MRTP (Modified Risk Tobacco Products)
- FDA SE (Substantial Equivalence)
- EU/TPD (European Union Tobacco Products Directive)
World Class Consultants
Enthalpy partners with the world’s best consultants and their publishers who help walk you through the entire regulatory submission process. Please reach out today for a list of our preferred consulting partners.
Tobacco Product Master File (TPMF)
Tobacco Product Master Files (TPMF) can be submitted to the FDA by any research laboratory, manufacturer, or individual voluntarily. TPMFs are a beneficial tool for manufacturers, component and ingredient suppliers, and researchers. Having the agency have access to a TPMF can assist with the tobacco product submission process.
Enthalpy Analytical has provided the FDA with our own tobacco product master file. Enthalpy’s TPMF references all of Enthalpy’s proprietary, in-house developed HPHC methods, validations, and standard operating procedures.
The TPMF is a truly beneficial tool for researchers and manufacturers alike. It allows owners to reference data for multiple submission types including: PMTA, SE, and MRTP submissions to the FDA. Authorized parties who have been granted authorization to reference a TPMF by the TPMF owner (Enthalpy) can reference TPMF data, analyses, ingredient lists, and constituent testing, in support of a tobacco product submission. The FDA can then access and review the trade secret and/or confidential information as part of the authorized party’s submission without that party seeing or accessing the TPMF owner’s confidential information. When a TPMF is established with FDA, it can be referenced by the TPMF owner and/or an authorized party through providing a letter of authorization.
If you would like authorization to reference Enthalpy’s tobacco product master file please email our team to get a Letter of Authorization (LOA) sent on your behalf for the agency to access Enthalpy’s TPMF.
