Post Marketing Surveillance

Maintaining and keeping your product on the market

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

Product-journery
Product Journey

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

Post Marketing 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 Marketing Surveillance services involve?
Broughton 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 Product Development (PD). Our team of highly experienced scientists, regulatory experts and scientific consultants have the necessary knowledge to support and navigate the relevant mandatory programme.
Product Development (PD)
Group 22
Service offered:
  • 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-vitro, in-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.
PMS-graphic

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 approch

Broughton offers a wide range of services, exclusively dedicated to supporting companies operating in the NGP sector. This full-service consultancy supports regulatory submissions and enables new product development to create a smoke-free future.

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