Documentation and Regulatory

Submission Support

YalePharma has extensive experience in DMF and CMC preparation, for providing regulatory support for IND, NDA, and ANDA submissions.

Regulatory Submission Services

Paper and electronic submissions (Pre-IND, IND, CTD, NDA, device and biologics)
Pre-clinical toxicology protocols and reports
Clinical study reports, investigator brochures and serious adverse event reporting

CTD services:

CTD templates
eCTD
Overviews and summaries
Converting existing documents
Full publication and submission capabilities