An initial review by Pharmalink revealed that the dossier was well-prepared but had deficiencies in various sections.
The Pharmacovigilance system would not have met the MHRA requirements and various sections of Module 1 of the dossier required updating.
Pharmalink Consulting's Mumbai office quickly put together a project team with consultants experienced in the different areas.
Pharmalink updated the PIL and carried out the User Test. At the same time, a PV expert began working with the client to update their PV system.
Pharmalink completed the task by submitting the dossiers to the MHRA on behalf of the client.
