Repeatedly Unlocking Success: West Coast Biotech successfully prepared for their Type B Meeting with timely technical support
Background One of our repeat clients, a West Coast Biotechnology company, needed help with writing and strategic input for their Meeting Request Letter and Briefing Book. This was in preparation for a Type B Meeting with the FDA following a preliminary Breakthrough Therapy Designation Request (BTDR), Preliminary Meeting and Type A Meeting. Challenge The preparation…
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Morula Health
IND to IMPD Adaptation to Open Sites in Europe and Israel
Morula Health’s expertise and quick solution allowed for easy adaptation of an IND to IMPD for one of our clients.
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