There are four possible routes to authorisation of products within Europe. The choice of procedure should be one of the key factors to consider in your regulatory strategy. Even if the product is mandated to use the centralised procedure, you will need to understand the procedure and consider how best to liaise with the authorities, what options are available for dialogue, timelines and many other factors.
Diamond Pharma Services can provide the following support:
- Full assistance and advice on all European procedures, national, mutual recognition, decentralised and centralised, including US support
- Support throughout the procedure to final market authorisation
- Liaising with regulatory authorities on your behalf
- Strategic input into the choice of procedure and related gap analysis
- Review of potential options such as orphan drug, accelerated review, exceptional circumstances, options for small and medium sized enterprises (SME) and support with related scientific advice.
It is essential to ensure that a regulatory dossier for submission to the regulators meets requirements in terms of content, format and quality of preparation. This is what the regulators will read and review to make an assessment of your product. Diamond Pharma Services can make full Marketing Authorisation Applications (MAA), abridged MAA or Bibliographic Applications.
Our team have written and prepared a diverse range of dossiers and we provide expert writing services for:
- Non-clinical overviews and summaries
- Clinical overviews and summaries
- Quality overall summaries.
Our Regulatory Operations team coordinate publishing activities for EU and US using a fully validated Extedo eCTD system.
Patient Information Leaflet (PIL) readability testing is a legislative requirement for all medicines in Europe.
All medicines are required by European and UK law to be accompanied by a Patient Information Leaflet (PIL) setting out comprehensive information which is accessible to and understandable by those who receive it, so that they can use their medicine safely and appropriately.
Diamond BioPharm Ltd offers a comprehensive PIL readability solution from new studies to bridging reports.
e-Liquids and TPD Notifications
Diamond has worked with global e-liquid companies since 2013 to ensure they are compliant with the requirements of the Tobacco Products Directive (2014/40/EU). We have helped clients to develop their EU regulatory strategy and to assess the quality, safety and market requirements including:
- GMP site assessment
- assist in Emissions and toxicological monograph vendor selection and report data evaluation
- EU Product notification authoring, assessment, submission & follow up through ECAS
- Labelling & leaflet authoring & assessment
- Cross border sale applications.
Diamond can also prepare annual reports and assist clients in scientific advice meetings with competent authorities, and act as the central point of contact with authorities.