Pharmaceutical Lab: MAA Dossier

The Challenge: Critical EMA Submission

A mid-sized European pharmaceutical laboratory urgently needed to file a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA). The volume was substantial: 3,000 pages covering modules 1 to 5 of the CTD (Common Technical Document) format, which included pharmaceutical quality, non-clinical data, clinical data (Phase I-III studies), the Summary of Product Characteristics (SmPC), and the patient leaflet.

The timeframe was critical: just 10 calendar days for the entire translation, coupled with strict terminology requirements aligned with ICH (International Council for Harmonisation) guidelines and MedDRA (Medical Dictionary for Regulatory Activities) terminology. Any terminological inconsistency could trigger an EMA rejection, potentially delaying the drug's market launch by several months and leading to significant financial impact.

The Asiatis Solution: 24/7 Orchestration

To meet this exceptional challenge, Asiatis deployed a bespoke framework combining highly specialized human expertise with non-stop project management. We assembled a dedicated team of 8 native PharmD translators (holding a Doctor of Pharmacy or a PhD in biomedical sciences) deeply specialized in regulatory affairs.

Results: Successful Regulatory Filing

• Strict adherence to the express deadlineThe complete dossier was delivered on the exact agreed day, empowering the client's regulatory team to execute the EMA submission within the planned time window.
• 100% EMA ComplianceNo terminological or structural objections were raised by the European Medicines Agency post-submission.
• Zero quality returnsThe exceptional quality of the medical translation enabled a seamless first-pass validation by the client's internal clinical team.