One of Pharmalink Consulting's experienced consultants based in the Mumbai office received the CD containing the dossier and began work immediately to prepare a complete Gap Analysis report of the dossier with suggested corrective actions.
In addition to the task, Pharmalink's expert prepared a full Regulatory strategy document and highlighted what else, apart from the technical information, would have to be submitted to the EDQM and in what format.
The work took the consultant 24 hours to complete and was delivered to the client a few days after the initial query was made. The company took the report back to their technical departments to decide on their next steps.
