Following a successful market authorisation, you have a regulatory obligation to ensure your product is appropriately controlled and monitored once in the market.

Optimising life-cycle management for your product is an important consideration throughout all development stages and what happens once it enters the market is of equal importance to how the product is developed in the pre-market setting.

Product Journey

Throughout the product’s life-cycle journey, safety and quality aspects along with human behaviour factors are monitored and addressed with appropriate strategies implemented to minimize risk to the consumer.

Post Market Surveillance (PMS) responsibilities are complex. They encompass multidisciplinary functions within a business, and involve in-depth gathering and analysis of data which must be submitted on a frequency agreed with the regulatory authority.

What do Post Market Surveillance services involve?

Broughton Nicotine Services can provide you with subject matter expert support to execute your post market surveillance plan for the lifetime of the product, including early product inception/ideation during New Product Development (NPD). Our team of highly experienced scientists, regulatory experts and scientific consultants have the necessary knowledge to support and navigate the relevant mandatory programme. 

Post Market Surveillance Services offered by Broughton Nicotine Services include:

Service compilation:

  • Product Changes– Review of planned or completed changes to product specification and manufacturing processes, provision of an impact assessment report and submission to regulatory agencies.
  • Product User Surveillance– Design and testing of post-market consumer studies based on FDA feedback and full analysis of on-going and completed studies, including compilation of summaries and submission of final reports to regulators.
  • Literature Review (Clinical and Non-clinical) – Full scientific literature review including new in-vitroin-vivo,and clinical data across published peer reviewed journals and scientific databases.
  • Adverse Events – Analysis of adverse event data from consumers to identify trends related to use of the product. Compilation of data, impact assessment and report writing for submission to regulatory authorities.
  • Labelling – Review of labelling change requirements and reporting changes to regulators.
  • Appropriate for the Protection of Public Health (APPH) – Prepare ongoing assessments that demonstrate whether the rationale to support APPH is still appropriate considering new data, adverse events, and sales information.

PMS5

 

 

Working in partnership, we offer a flexible approach to provide the necessary support where it is needed most. We can assist you with any or all the above, providing update summaries for regulatory submission.

Our Project Management team work closely with you, every step of the way and help you meet your regulatory compliance obligations to keep your product on the market and appropriate for the protection of public health.

A fully integrated approach 

Broughton Nicotine Services offer a wide range of services, exclusively dedicated to supporting companies operating in the ENDS sector. This full-service, when integrated with our other ENDS-focused analytical and scientific services provided, supports regulatory submissions and enables new product development to advance a smoke free future.

New call-to-action

Resources

Leaflet

Overview of our full-service PMTA compliance solution, from planning through to compilation and submission.

Guide

Understand what’s involved in a PMTA and how the recommendations relate to your ENDS business.

Leaflet

Download our leaflet for an overview of our comprehensive services to support the ENDS industry from regulatory submission to maintaining compliance.