New Drug Application (NDA) /Biologics License Application (BLA)/ Abbreviated New Drug Application (ANDA)

New drug product applications with US-FDA are broadly classified under three main categories: New Drug Application (NDA) for small molecules (new chemical entity- NCEs) or Biological License Application (BLA) for biological/ biosimilars/ biotechnological products or Abbreviated New Drug Applications for the generics. Some products may be eligible for assessment under different pathways such as accelerated approval or priority review. DLRC has expert knowledge and experience of all the US registration pathways and can support your company through the FDA submission and review process.

EU Marketing Authorisation Application (MAA)

An MAA is an application made to the European regulatory authority (either the EMA or National Competent Authorities) to gain an approval to market a medicine and can be submitted via a variety of mechanisms including Centralised, Mutual Recognition Pathway (MRP), and Decentralised Procedures (DCP). Some products may also be eligible for approval under different pathways such as conditional authorisation or accelerated assessment. DLRC has extensive expertise in all the regulatory pathways for the EU and can advise on the best strategy for your product as well as support you through the submission and review process.

UK

Following the UK’s departure from the EU, there are now multiple options for the approval of medicines in the UK including fully national applications, recognition of an EU Centralised Approval and participation in various work-sharing initiatives with other global regulators including Project ORBIS and the New Active Substance Work-sharing Initiative. DLRC can advise on the optimal strategy for your UK registration as well as support you through the whole review process.

Pre-submission Meetings

Pre-submission meetings provide an early opportunity to engage with regulatory agencies and are critical to facilitate the validation and the smooth evaluation passage of marketing applications. DLRC have successfully led pre-submission meetings with the FDA, EMA and CHMP Rapporteurs as well as with local competent authorities and therefore have the expertise and experience to help you plan and execute these interactions to optimise your submission strategy.

Invented Names

The invented name of the medicinal product should not cause confusion, be mis-leading or present any kind of a safety risk should the product be approved. As such both the FDA and EMA have a stringent name review process. DLRC has great experience in the requirements for invented names and in supporting clients with gaining global trade name approvals.

Oral Explanations

In the EU, an Oral Explanation is held at the end of the review procedure if major approval issues remain. Preparation for these interactions is key to maximising the chances of approval. DLRC are highly experienced at preparing and supporting clients through the process and providing high quality advice on strategy for the interactions as well as ensuring the team are fully prepared for the meeting itself.

Re-examinations

Unfortunately, sometimes it is not possible to resolve all issues with an application during the Centralised Procedure and a Negative Opinion is received. It is however possible to request a re-examination of the application. Ensuring optimised strategy and execution for this second chance is key to the outcome. DLRC can assist with re-examination procedures even where we have not previously been involved in the submission to help you reach a successful conclusion.