Expert advice and support for early-stage discovery programs seeking new treatments for drug addiction, psychiatric and neurological disorders, obesity and binge-eating disorder. All aspects of strategy, screening and project support management are performed with a strong focus on clinical success and regulatory approval.
Our services include:
- Design of innovative non-clinical studies, preparation of experimental protocols, outsourcing and monitoring projects, the analysis and interpretation of data, and preparation of regulatory-standard reports
- Strategic assessments of therapeutic indications, including competition from current therapies, market opportunities, and novel drug targets
- The design of screening strategies with key ”Go/No Go” decision points
- Long-term collaborations bringing our expertise into our clients’ research projects to facilitate and expedite the discovery and selection of drug candidates for clinical development
- The guidance, design and management of non-clinical efficacy and safety testing to differentiate clients’ drug-candidates from the competitors
- Early-stage abuse and dependence liability assessments to de-risk programs
- Ensuring FDA and EMA compliance for the design and conduct of studies
DevelRx’s consultants each has at least 30 years of experience in R&D, managing programs at Boots Pharmaceuticals, Knoll Pharmaceuticals (BASF Pharma), and in RenaSci with a range of external biotech and pharmaceutical industry clients. We have initiated clinical development of drug-candidates and supported successful development and registration of 16 new drugs for the treatment of opiate withdrawal, ADHD, binge-eating disorder, schizophrenia, opiate-induced constipation, Parkinson’s disease, epilepsy, anaesthesia, obesity and type 2 diabetes. As globally acknowledged experts in evaluating drug abuse risks, we provide a key service in de-risking early-stage projects in therapeutic indications where regulatory approval and controlled drug scheduling are major obstacles to commercial viability.
- Treatments for substance use disorders
- Binge-eating disorder
- Parkinson’s disease
- Alzheimer’s disease
- Type 2 diabetes
Get in touch to find out how we can help you.