Ensuring that you plan proactively for any questions that might come back from the regulators, and responding and interacting effectively with the agency in a timely manner, is critical for your submission to gain approval. We support you through the whole assessment phase.
Example of services
- Full MAA Management and Preparation
- On-Site Placements
- Publishing and Regulatory Lifecycle Management
- Advisory Board Submission Review
- Gap Analysis of MAA
- Preparation of Responses
- NDA Advisory Board Response Review
Though the submission of your Marketing Authorisation Application (MAA / NDA / BLA) might seem the end of a long journey, it is only the beginning. The assessment phase itself can be a protracted process with questions arising on both sides and interactions with the agencies that may prove critical to where your product can go in the future.
NDA supports you through the whole assessment phase. We assist you in managing the procedures and ensure you have optimal response and hearing strategies in place. We can support you with labeling negotiations and help you write the required responses. NDA’s Advisory Board provides a guiding hand and can review your response package to give you a clear view on questions that may arise.
Pharmacovigilance and Quality
Example of services
- Response Strategy and Support
- Inspection Preparedness
Pharmacovigilance is an integrated part of your submission. Being prepared to respond to questions relating to your safety monitoring and post approval conditions is just as important as other regulatory considerations.
With the new Pharmacovigilance legislation, the probability of an Agency inspection has also increased giving rise for even more need to be prepared before the event happens.
NDA’s strategic input and hands-on support to the questions raised by agencies embed pharmacovigilance as an integrated component to your development plans. We assist you to ensure that your organisation, processes and systems are ready for Agency inspections.
HTA (Health Technology Assessment)
During the Assessment phase, you need to respond to questions and decisions made by payers during different stages of the assessment.
NDA will help and support you across all of these processes.