Our team of leading scientific and regulatory experts across the global nicotine market are here to help you navigate through the product life cycle journey for your chosen regulatory pathway, these include:

  • US Premarket Tobacco Product Application (PMTA)
  • Medicinal Product (MAA)
  • EU Tobacco Products Directive (TPD)
  • Modified Risk Tobacco Product (MRTP)

Our experienced team have worked on major tobacco harm reduction regulatory projects to enable smokers to access scientifically substantiated reduced-risk products and are ready to advise on scientific strategies in areas including new product development, regulatory submissions, and post marketing surveillance activities.

New Product Development (NPD)

We design and execute rigorous scientific studies for your new product, to facilitate final design and marketing claim decisions, aligned with the requirements of your chosen regulatory pathway.

Services we offer:

  • Formulation Development and Device Design Assessment
  • Analytical Development
  • Product Characterization
  • Health and Safety Assessment
  • Quality and Manufacturing Assessment

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Regulatory Submissions

Our subject matter experts across all the regulated scientific fields work with you to develop strategies to deliver on your project objectives. Our established track record of engaging with regulatory authorities enables us to support clients with expert representation at every stage of the process.

Services we offer:

  • Scientific strategy and regulatory briefing packs
  • Compilation of appropriate scientific reports and narratives to support regulatory submissions
  • Submission strategies

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Post Marketing Surveillance

Following your successful marketing authorisation, we can provide you with subject matter expert support to execute your post marketing surveillance plan.

Services we offer:

  • Regulatory reporting for adverse events, complaints and recalls
  • Dossier updates and substantial changes
  • Non-clinical support for product safety, literature reviews, database monitoring and reporting
  • Clinical support for post-market human behaviour and demographic monitoring and reporting
  • Scientific support for annual safety reporting including compilation of QC batch release and stability data

We work with you to develop analytical strategies that generate high-quality and meaningful data.

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Why our clients work with us

We believe in developing collaborative relationships with our clients. We give them the confidence and trust that we will deliver on their expectations and in line with their goals. We are here to provide you more than test results, and we have the experience to help you continually deliver safe and effective products to market.


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