Case Study: Turkish Pharmaceutical Manufacturer — Urgent Sample Submission for MoH Analysis1. The ClientA pharmaceutical manufacturer based in
Istanbul, Türkiye, with a medicine registration process already underway in Russia.
Initial Situation: During the sample submission stage for analysis, the Ministry of Health (MoH) requested
additional supporting ingredients that were not specified in the Normative Documentation (ND) or the analysis procedure.
2. The Challenge· The MoH set a
strict deadline of 5 business days for sample submission.
· The required additional ingredients were
not available in the client's existing documentation and had to be sourced separately.
· It was
impossible for the client to send the samples from Türkiye within the given timeframe due to logistical and customs constraints.
· Any delay would risk the entire registration process.
3. Our SolutionSoloreg acted immediately and took full responsibility for resolving the issue locally:
1.
Local Sourcing: We identified and
arranged the required additional ingredients within Russia, without relying on the client's supply chain.
2.
Temperature-Controlled Logistics: We organized the full
controlled temperature protocol at -20°C to ensure the integrity and compliance of the samples.
3.
On-Time Submission: We successfully prepared and
submitted all samples to the MoH within the 5-business-day deadline — fully compliant with the required conditions.
4. The ResultIndicator | Achievement |
Deadline | Samples submitted on time within the 5-business-day limit. |
Compliance | Full adherence to the -20°C controlled temperature protocol. |
Registration Status | The registration process continued without delay or interruption. |
Client Impact | The client avoided a potential rejection or suspension of the registration due to missed deadlines. |
