Our Consulting Service serves to assist academic investigators through the diverse tasks required to bring discoveries from the academic realm into human clinical testing. We consult on strategic and specific FDA-requirements with experts in pharmaceutical development and manufacturing, toxicology, and regulatory hurdles, and assist with clinical trial design, data collection, and operations.
Federal Small Business Grants
We provide assistance with the strategy, writing, assembly and submission of SBIR and STTR applications.
We provide drug development companies and academic investigators with expert services related to drug development, such as GMP manufacturing, toxicology, US and EU regulatory, and document preparation.
Drug Development Programs
We provide small businesses and academic investigators with expert and experienced assistance in preparing applications to programs which support the preclinical development of drug candidates.
FDA and EMEA Orphan Drug Applications