Challenge:

A biotech company working in the microbiome space engaged Alacrita to provide advice about regulatory strategy and to prepare for and conduct a pre-IND meeting with the FDA. The product in question was a massively multiplex composition that presented complex CMC and assay issues.

Solution:

Alacrita's regulatory specialists with experience in the microbiome arena worked closely with the client's management team to develop a regulatory approach to the FDA. Alacrita guided the client team, which took primary responsibility for drafting the pre-IND briefing document, providing critical review and direction along the way. We worked closely with the client to develop a series of key questions for FDA and the pre-IND request was submitted. Due to COVID-19 restrictions, the FDA provided written responses only, but nevertheless the FDA views were very informative and were used to initiate an IND process.