Hobbled On The Home Stretch Of First-To-File Race?

PSA’s Regulator Query Management Helps

A bonus: lessons for other project-based industries

You are on the home stretch. You developed your new drug. You finished development and did pilot-to-production scaling. Your supply chain is set up. Your RA (regulatory approval group)has filed the product’s dossier to your drugs regulators ( e.g. FDA). Your project teams have more or less nailed the timelines.

The finishing line in your sight. After a while your RA gets an email from the regulator attaching a pdf file listing deficiencies in your submission. Time trickles away as the RA team chases various departments for resolving the queries.?

One day, your management discovers that your company has fallen behind in the first-to-file race. The 6 month window of exclusivity for selling your new generics drug may be closing since your competitors are also in the race.?

Suddenly it doesn’t feel like a home stretch at all.

What went wrong? What goes wrong?

Typically, a regulator's query file has 5 to 20 deficiencies categorized according to the section numbers of the dossier, missing documents, and insufficient information. The deficiencies may be related to clinical trials ( e.g. data traceability, statistical analysis), manufacturing ( quality control procedures, validation of critical processes), regulatory compliance ( e.g. documentation, risk management), supply chain management, etc.

The queries are diverse, therefore responding to them and resolving them to the satisfaction of the regulatory authorities requires cross-functional consultations. Your RA team must coordinate it.

Currently, managers in most companies rely on spreadsheets shared by emails for query management. Lengthy email threads and newer and newer versions of spreadsheets make tracking the status of each query difficult.

The current methods make cross-functional collaboration difficult.

The deficiencies get dispersed in several email threads, therefore the top management has limited visibility into the specific bottlenecks.? Once RA submits the drug’s dossier for registration, the feeling that the job has been finished takes over. Everyone moves on to other jobs.?

But the job is unfinished. Setting high priority for this unfinished work gets delayed because?of poor visibility to top management.

You need query management as a part of your dossier preparation and overall NPD project management. A modern PSA excels here.

Your query management system must provide tracking of each deficiency with granular details like section no., department(s), nature and subject, person(s) assigned, action items, current status, and planned and actual dates of completion. The tracking system must flag warnings related to pending actions before it is too late.

The query management system also needs to be a vehicle of collaboration among concerned people from multiple departments.

A collaborative query management system with high visibility is the only way to ensure that you don’t get hobbled by queries and deficiencies pointed out by your regulatory authorities.

A modern PSA? establishes data paths to all parts of?legacy enterprise systems and generates useful information based on a single version of the truth. Therefore, it is well placed to provide the above query management system.

Let AI put springs in your stride near the finish line.

AI embedded in PSA is trained on your NPD project information including regulatory queries received in the past.

Forewarned is forearmed

The embedded AI can alert you the potential deficiencies in your drug’s dossier. Your RA team can get the required corrections done before submission.

Augmented responses

The AI system analyzes responses to similar queries in the past and suggest actions, saving time to manually search for the precedents.

A PSA-powered, AI-enabled query management puts you on a fast track to the finish line. It reduces deficiencies, aligns resources for query and deficiency resolution, enhanced collaboration, and speeds up closing of all deficiencies.?

Bonus: lessons for other project-based industries

Whether you are in pharma, IT, consultancy, EPC, or any other project-based sector, our experience in pharma provides valuable lessons.?

During and after implementation of projects, stakeholders raise various kinds of issues. Their issues often need cross-functional consultations before they can be satisfactorily resolved.?

The cross-functional nature of the issues makes them very precious. It is better to view the issues as an opportunity to understand stakeholders’ needs and deficiencies in your offerings or processes rather than as mere problems to be solved and put away. Therefore we need to put serious thoughts in how we manage queries by regulators, customers, and other stakeholders.

The above query management system is a perfect answer to tracking, collaboration, and visibility needed in preventing and resolving the issues.?

Last but not the least, the system leverages learning from previous projects.

Kytes, an AI-enabled PSA, puts all the above functionalities and more at your fingertips. Would you like to know more or witness a demo?

Contact us at [email protected]