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Regulatory Consultancy

Helping You Meet Your Regulatory Obligations Through Expert Advice and Submission Support

With our focus on strong product science relevant to the regulatory pathway, we can optimize your company’s success and reduce its risk. Our regulatory and scientific subject matter experts excel at developing strategic regulatory and compliance programs to ensure regulatory approval. 

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Building Successful Regulatory Strategies 

Helping you achieve regulatory approval or ongoing compliance in an efficient and cost-effective way. Our scientific and regulatory subject matter experts have years of experience creating successful submissions. They will bring new insight and understanding to your regulatory project and specialize in designing industry-leading scientific testing strategies and interpreting test data to build compelling regulatory narratives. 

  • Scientific regulatory consultancy
  • Scientific problem solving
  • Dossier writing and submissions
  • Post market compliance

 

 

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Bespoke Solutions to Meet Your Unique Requirements

Ensuring your regulatory project remains on track and within budget is crucial for success. All our regulatory projects are led by a dedicated Technical Project Lead with years of relevant industry experience and supported by a Program Manager who ensures smooth coordination across the different work streams and proactive communications with your in-house team.

Your regulatory project is unique. We build a bespoke scientific regulatory strategy that meets the individual needs of your product, brand, and company business strategy. The process will start with a strategy definition phase to ensure your business objectives, ways of working, and internal requirements become integral to how our consultants deliver the project for you.

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The Art of Regulatory Submission Writing

Your regulatory submission narrative is a piece of powerful strategic scientific communication representing your company, your product, and your science articulated into a compelling and thought-provoking argument that can facilitate timely regulatory approval. Our scientific and regulatory experts excel at technical writing, creating compelling regulatory dossiers, and ensuring efficient submissions, tracking, and post-submission responses.

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Global Regulatory Pathways 

Medicinal Marketing Authorization (MAA)

Enabling a nicotine delivery product to be marketed as a nicotine replacement therapy (NRT) in the European Union and UK markets.

Premarket Tobacco Application (PMTA)

A PMTA Marketing Granted Order is required for any tobacco or nicotine-based product to be marketed in the U.S. market.

 

Click here to read more about PMTA.

Modified Risk Tobacco Product (MRTP)

The MRTP sets the bar higher than the PMTA authorization. PMTA data often serves as a basis for an MRTP application.

Tobacco Product Directive (TPD) and Tobacco and Related Produce Regulations (TRPR)

TPD/TRPR notification is required six months before placing a nicotine-based product on the market in the European Union and UK markets.

 

Click here to read more about TPD/TRPR.

CA/CE Markings for the EU and UK

Helping to evaluate products to see if they comply with the relevant conformity assessment procedures and meet document requirements in the EU and the UK post-Brexit. We offer compliance support relating to UK CA and EU CE marketing requirements for a range of products.

  • Medical devices
  • E-cigarettes and vape devices
  • Novel inhalation devices
  • Low-voltage electrical equipment

 

CBD Novel Food Regulations

Ensuring product quality and safety in line with European Union and UK CBD Novel Food Regulations.

 

Click here to read more about CBD Novel Food Regulations. 

Speak to an Expert

Talk with a scientific regulatory expert to discuss your project and learn how we can help accelerate your product to market to maximize your success.



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Consultancy Services Resources

Learn more about how we can help bring your product to market through our scientific and regulatory consultancy services. 

PMTA-Guide-For-NGP-businesses

PMTA Guide For NGP businesses

At Broughton, our consultants have deep industry knowledge across all the elements required for a PMTA. We guide you through and generate the required data, to ensure that FDA finds your applications strong and compelling.

 

Click to download

Whitepaper:-A-Summary-of-the-Legal-Status-and-Regulatory-Pathways-to-Market-for-Cannabinoid-Products-in-the-UK-Market

Whitepaper: A Summary of the Legal Status and Regulatory Pathways to Market for Cannabinoid Products in the UK Market

Broughton summarises the regulatory pathways available for cannabinoid products in the UK market and the legal requirements for each potential market route. 

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A-Guide-To-TPD-and-TRPR

A Guide To TPD and TRPR

An overview of the Tobacco Products Directive and Tobacco-Related Products Regulations. Get the straightforward answers you’re looking for when it comes to TPD and TRPR analysis.

Click to download

Industry Insight and Expert Opinion

Learn more about our activities and gain insight from our scientific and regulatory experts

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