By managing your entire submission or key parts of it, we ensure that your data is presented most effectively, aligned to the needs of regulators and payers alike. This will ensure the best possible chances for approval and reimbursement.
Example of services
- Full MAA Management and Preparation
- Onsite Placements
- CMC (Quality), Non- Clinical & Clinical Data Review and Gap Analysis
- Publishing and Regulatory Lifecycle Management
- NDA Advisory Board Submission Review
Managing a full regulatory submission is not just a matter of knowing what the guidelines are telling you. How it will be interpreted or when it is appropriate to argue how your drug is different are equally important, as is the management of internal stakeholders.
NDA has successfully managed the delivery of over ten full Market Authorisation Applications (MAAs)/NDAs/BLAs and supported close to 100 additional submissions over the past five years. This work has included the preparation of all CTD sections. Through this extensive exposure to the regulatory requirements and the realities of submission management in all its facets, NDA provides you with expertise and experience that is very difficult to match in any one pharmaceutical company.
NDA supported over 40% of the new medicinal products that were approved in the EU during 2013-2016.
Pharmacovigilance and Quality
Example of services
- PV Submission Strategy and Review
- PV Authoring and Process
- Risk Management Plans
- Pharmacovigilance System Master Files
Today, pharmacovigilance (PV) is of strategic importance in setting up your submission strategy and delivering the right documentation and supporting rationale to the European Regulatory Agencies.
NDA supports your PV activities through the submission phase, with critical review of your submission strategy and proposed post approval commitments, as well as authoring of critical documents and development and auditing of key processes. This ensures increased chances for approval with the right post approval commitments in place to secure patient safety and efficient management of risks without unnecessary activities.
HTA (Health Technology Assessment)
Building a value file for submission needs much consideration, factoring in the complexities with multiple HTA, pricing and reimbursing agency’s in EU. Based on the evidence generated, the submission needs to be adapted to echo every agency’s expectations.
At NDA, we can support you in building your case to the payers and simultaneously help you to align regulatory demands for post authorisation follow-up when the product is in real-life use. We will do this by giving you an assessment and second opinion on your value file before your pricing/reimbursement application.