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

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

 

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 assistance or referrals for preparation and submission of Investigational New Drug Applications to the FDA.

 

FDA and EMA Orphan Drug Applications

image369We assist  small businesses and academic investigators with experienced consultants in their target area for preparing applications to the FDA and EMA for Orphan Drug Designation.