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.
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.
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.
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.
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.
Overview of our full-service PMTA compliance solution, from planning through to compilation and submission.
Understand what’s involved in a PMTA and how the recommendations relate to your ENDS business.