Regulatory Support

Our team has an impressive history when it comes to regulatory support working in TPD, PMTAs, Medicinal Products and combination products. We offer a complete service specialising in Nicotine Containing Products (NCPs) and Inhaled Drug/Device products and will provide you with as much or as little support you require.

We support both pharmaceutical products and electronic cigarettes through the entire regulatory process, from design to post launch activities, including:

Product Development

  • Product design to ensure your product will comply to any standards required for product compliance
  • Assist in primary packaging bringing to bear our extensive knowledge on material interactions, stability considerations
  • Product design and drug/device interaction including electronic control of temperature, material incompatibilities
  • Testing methodology and specifications
  • Product optimisation for compliance and consumer/patient compatibility

Regulatory Strategy

  • Develop an appropriate regulatory strategy with you to meet the needs and aspirations of your organisation, whether that be registration under the Tobacco Products Directive, FDA registration or with a National Competent Authority, such as the MHRA/EMA.
  • Regulatory strategy for Medical Devices

Regulatory Activities

  • Compilation of complex or bespoke TPD applications for tobacco products
  • Compilation of PMTA for FDA for new electronic cigarette products
  • Compilation of MAA, IMPD for medicinal products
  • Dossier submission and management

 

Product Assessment Service

Initial product assessment and liquid/formulation analysis

Detailed budgetary assessment of requirements


Toxicology Assessment

Liquid composition

Aerosol composition


Product Risk Assessment and Output Testing


Labelling Assessment and MSDS Support


Child Resistance Closure Testing


Test Method Design, Validation and Support


Ad Hoc Consultancy and Project Management