An Indian pharmaceutical manufacturer who had submitted their medicines for EAEU registration through another Moscow-based CRO (Contract Research Organization).
Initial Situation: The client's application received a query on clinical aspects from the Ministry of Health. The previous CRO had failed to provide sufficient data on product safety and efficacy and had incorrectly analyzed the product pathway without clinical studies.
2. The Challenge

• The Ministry of Health issued a clinical query with a maximum reply period of 90 days (standard).
• The previous CRO declined to handle the situation and could not arrange the required bioequivalence studies within the tight timeframe.
• Without a proper clinical response, the product faced rejection — putting the entire registration at risk.
• The client had no local capability to organize clinical studies in Russia on such short notice.

3. Our Solution
Soloreg took over the case and acted decisively:

1. Case Takeover: We immediately assumed full responsibility for the case and assessed the query requirements.
2. Clinical Partner Engagement: We arranged clinical studies through our authorized and approved clinical institutional partner in Russia.
3. Bioequivalence Studies: Our partner conducted the required bioequivalence studies within the strict 90-day frame.
4. On-Time Submission: We successfully prepared and submitted the required clinical studies to the Ministry of Health on time.

4. The Result