Repairing an error in technical dossier in 19 days
The client received a registration refusal due to errors in the chemical part. We entered the project in emergency mode, corrected the data, and submitted a re-application that passed without comments.
The Office for Registration of Medicinal Products rejected documentation for a new series of drugs from VitaLab Kraków. A critical error in Module 3 of the dossier stopped the market entry of a product that distributors were waiting for. We repaired the documents and obtained office approval in less than three weeks.
The challenge
VitaLab Kraków was preparing for the premiere of a cardiology drug. The internal registration department made a mistake when describing the active substance (API) specification. URPL inspectors found 14 inconsistencies that disqualified the application. Every day of downtime cost the company exactly 4,820 PLN in lost margin. The previous consulting agency claimed corrections would take a minimum of 3 months. The client risked missing the autumn purchase window in large pharmacy chains.
Our approach
We started work on September 2, 2024, with a full audit of Module 3. Marek Sokołowski from SanofyvisionIndia Pharma Relations analyzed the certificates of analysis provided by the foreign API manufacturer. It turned out that the problem was not the drug itself but the differences in analytical methods used in India and Poland. Instead of writing more requests for explanation, we immediately prepared the missing validations. The offices know us, so we knew how to formulate technical responses to avoid further questions. We acted in accordance with the act, without unnecessary paperwork.
The solution
We sent a 3-person technical team directly to the client's headquarters to speed up document flow. We contacted the active substance manufacturer and forced the submission of correct data in 7 business days, instead of the standard 30. We developed a complete Response Letter that corrected the errors pointed out by inspectors point by point. The documentation was rearranged in eCTD format, which eliminated technical errors during submission.
Results
Thanks to our intervention, the application was accepted by the office at the first deadline after supplementation. VitaLab Kraków avoided contractual penalties from distributors and introduced the drug for sale still in September.
Timeline
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September 2, 2024Technical dossier audit and detection of API validation errors
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September 9, 2024Receiving supplemented test results from the manufacturer in India
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September 16, 2024Submission of ready supplementary application to URPL in Warsaw
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September 21, 2024Receiving positive decision for entry into the register
"We were against a wall because deadlines were pressing. SanofyvisionIndia Pharma Relations took over the case and in less than three weeks closed the topic that our team had been struggling with for a quarter. Concrete deadlines, without unnecessary fluff."