Therapeutic & Medical Device
Product Development & Testing
(preclinical, prototype, final pivotal tests, &
cGMP, cGLP manufacturing)
Strategic counsel on related regulatory submissions
Medical writing & Regulatory submissions:
White papers, peer review publications.
Content for IND, DSUR, 505(b)2, Fast Track, 510k & De Novo applications
in compliance with the International Conference on Harmonisation guidelines.
Business services for start-ups & investors:
Preparation of investor-facing slide decks & executive summaries
Fundraising support: grants & investors
Due diligence
Product market fit & market research