Pharmalink Consulting turned to one of its experienced consultants with a track record specifically with the biotech product in question.
The consultant reviewed and updated the submission documents and provided a pragmatic corrective action listing prior to preparing revised QOS and Module 3.
The consultant added value by preparing a risk analysis alongside the required output, thus ensuring that the client was aware of potential issues once the filing was undertaken.
The work took 90 hours to complete and was delivered to the client in less than a month.
