On.Target Molecules Biotech — Pre-Submission Regulatory Engagement in Central America
bioaccess® is supporting On.Target Molecules Biotech, a U.S. oncology biotech, with a pre-submission regulatory engagement across El Salvador and Costa Rica — the early regulatory groundwork ahead of a potential first-in-human study.
Study facts
- Sponsor / company: On.Target Molecules Biotech
- Indication / area: Oncology
- Country: El Salvador, Costa Rica
- Study type: Pre-Submission Regulatory Engagement
Key metrics
- Engagement type: Pre-submission regulatory
- Markets: El Salvador & Costa Rica
- Status: In progress
- Area: Oncology
The challenge
Early-stage oncology sponsors must align their regulatory strategy with health authorities before a first-in-human study. On.Target Molecules needed an efficient Latin American pathway to prepare for regulator engagement.
bioaccess® solution
bioaccess® is running the pre-submission regulatory engagement — preparing and coordinating pre-submission meetings with the health authorities in El Salvador and Costa Rica.
Frequently asked
- What is bioaccess® doing for On.Target Molecules Biotech?
- bioaccess® is running the pre-submission regulatory engagement — preparing and coordinating pre-submission meetings with the health authorities in El Salvador and Costa Rica.
- Where is the On.Target Molecules Biotech engagement taking place?
- bioaccess® is running a pre-submission regulatory engagement for On.Target Molecules Biotech across El Salvador, Costa Rica in the oncology area. It is a pre-submission phase, not a completed study.
Run a similar trial: Clinical trials in El Salvador
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