PMTA
PreMarket Tobacco Applications

PreMarket Tobacco Application (PMTA)

  • FDA Meetings & Engagement
  • HPHC Testing
  • PMTA Strategy
  • Manufacturing Validation
  • Quality Management System Implementation & Tobacco Product Master Files
  • PMTA Filling
e-liquid pens

About the PreMarket Tobacco Application (PMTA)

Inter Regulatory adopt a pragmatic approach to the requirements of PMTA. We recognise that each of our clients has different needs, from straight forward applications to complex bridging and bracketing needs. Inter Regulatory is committed to finding pragmatic solutions to ensure that everyone from small self-mixing vape stores right through to multinational firms, such that the market continues to offer smokers a safer alternative to combustible tobacco.

Core to our strategy is the engagement with the Food and Drug Administration (FDA). As such, Inter Regulatory have developed a 4-Stage approach to PMTA development to facilitate a risk-based and cost-effective solution;

  1. Strategy Formation and Regulatory Engagement
  2. Generation of New Data to Support Products
  3. Compilation of Publically Available Data
  4. Compilation of PMTA, Review and Submission

Inter Regulatory has partnered closely with an A2LA/UKAS accredited laboratory operating to ISO 17025, a key requirement for laboratories responsible for the generation of data to support a PMTA, to provide a seamless service.

Inter Regulatory also offer Quality Management System (QMS) support to e-liquid manufacturers seeking to go through the PMTA process. Working with our experts we will develop and implement a QMS suitable for FDA compliance (to ISO9001 or GMP) and train you and your staff to take ownership of the system. Through this process, we will work with you to develop the required validation processes and data to meet PMTA requirements.

We are also experienced in the generation of Tobacco Product Master Files (TPMF), often used by flavour or device manufacturers to collate the necessary information (including confidential information) to enable their clients a swift PMTA submission.

Our Services

We offer complete PMTA project services including

OS meeting request

FDA engagement

Strategy development

HPHC testing

Stability and microbial testing

Tobacco Product Master File (TPMF) generation

Why Work with Inter Regulatory

  • A company with experience in regulatory compliance and FDA filings
  • Partnered with a laboratory that has internationally recognised accreditation (A2LA/UKAS)
  • A company with truly Global regulatory experience
  • A company led by quality
  • A company dedicated to the compliance of nicotine-containing products
  • Pioneering experts in ENDS regulation, responsible for the first and only medically regulated ENDS product
  • Dedicated project manager responsible for your project

Address

8 The Matchworks,
Speke,
Liverpool,
L19 2RF

FS 681824 Inter Regulatory. A company registered in England and Wales, Company registration number: 10841512

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