RenaSci

Consultancy

Consultancy image

 

RenaSci’s team has a successful track record in pharmaceutical R&D having assisted in taking over 30 candidates into clinical development and 10 drugs to the market. We provide consultancy to pharmaceutical companies, virtual R&D organisations, venture capitalists, financial analysts and specialist legal practices. 

Our therapeutic areas are: -

  • Drug abuse evaluations
  • Psychiatric and neurological disorders
  • Obesity
  • Diabetes

Consultancy is offered on all aspects of drug development including drug discovery, preclinical and clinical development, regulatory approval, intellectual property protection and market positioning.

Preclinical Discovery and Development

  • Target evaluation and validation
  • Pharmacological optimisation of lead series and drug candidates
  • Preparation of drug development plans
  • Differentiation from competitors

Clinical Development

  • Preparation of clinical development plans
  • Participation and organisation of Scientific Advisory Boards

Drug Abuse Evaluation

  • Study design and management
  • Abuse liability report preparation
  • 8-factor analysis report preparation (for Scheduling)
  • Face-to-face meetings with the FDA, DEA, EMA and other global agencies

Regulatory Affairs

  • Dossier preparation
  • Extensive experience of regulatory agencies, including Japan

Intellectual Property

  • Inventorship on 40 patents
  • Creation of 30 more patents for our clients
  • Expert witness support on intellectual property and drug pricing litigation

Strategy and Marketing

  • Evaluation of licensing opportunities
  • Due-diligence reviews
  • Strategic reviews of discovery and development portfolios
  • Participation on Scientific Advisory Boards