Marketing Authorisation
DLRC has extensive experience of successfully supporting global Marketing Authorisation Applications from pre-submission interactions through to product approval.
We can provide a range of support from strategic advice and document review to full authoring and publishing of the submission and responses (see our Medical Writing and Regulatory Operations and Publishing Services for more information on these activities). Whether you are a big pharmaceutical or a small biotech company planning to register your first product in the US, UK, EU or any other RoW region, DLRC has the capabilities to help bring your product to market.
Take a look at how we have helped some of our clients.
Based on a recommendation, DLRC was approached by a pharma company headquartered outside the EU to support them in breaking into the EU market with their portfolio of respiratory products.
DLRC advised on regulatory requirements regarding both the product and inhaler device. We were actively involved in review and preparation of the dossier and devised the regulatory strategy to ensure commercial goals were achieved.
DLRC managed multiple DCP procedures to successfully gain MA approvals across the EU. We are now managing multiple procedures for all types of inhaled devices with this client for further drug products.
Small EU Pharma Company with limited experience of MAA preparation, submission and review.
DLRC provided strategic and operational regulatory support to ensure submission of the MAA via the centralised procedure within a short timeframe. Working within the project teams, DLRC provided leadership and guidance to ensure that the MAA dossier was prepared in a timely fashion and to a high standard. Support included Agency pre-submission meetings, dossier preparation, document review, strategic regulatory input, liaison with senior management and working with external partners and consultants. DLRC continued to provide support during the MAA assessment process.
The product was successfully approved and DLRC continues to provide post-approval support.
Work collaboratively with a US biotech with no previous EU filing experience to submit an EU MAA to an aggressive timeline.
The client’s BLA dossier was under preparation when DLRC was asked to provide European services and expertise. As well as European expertise, our staff have experience with NDAs and BLAs and this knowledge facilitated our collaborative teamwork to support adjustment of an FDA focused dossier for the EU.
DLRC’s expertise in EU requirements allowed us to pre-emptively identify the need for a new pharmaceutical form, recognising a difference in regulatory approach between the FDA and EMA, and we developed a strategy to resolve the issue.
DLRC coordinated pre-submission agency meetings and as timelines progressed, the client requested that DLRC lead the authoring of the EU quality overall summary and EU non-clinical and clinical overviews.
DLRC provided EU regulatory leadership to ensure the joint team overcame challenges and we were able to publish and submit the dossier and obtain successful validation in the timeframe that the client required.
