Consulting Services

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

image12961

We provide assistance with the strategy, writing, assembly and submission of SBIR and STTR applications.

 

Business Development

image1298We assist with expert services related to business development, ranging from the preparation of CDAs to introductions for partnering.

 

Intellectual Property

 image318We provide expert and experienced intellectual property legal consultation to small businesses and academic investigators.

 

Pharmaceutical Development

image1606We 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.

 

  IND Applications

FDA-2 We provide  academic investigators with expert assistance in the preparation and submission of Investigational New Drug Applications to the FDA.

 

FDA and EMEA Orphan Drug Applications

image369We provide small businesses and academic investigators with expert andimage16161 experienced assistance in preparing applications to the FDA and EMEA for Orphan Drug Designation.