Consultancy
RenaSci’s team has a successful track record in pharmaceutical R&D having assisted in taking over 20 candidates into clinical development and 5 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
