What we will do
When there is a problem or gap, we will become your long-term partner and create a way together to resolve the issue.
Why are we so confident?
Our CNS teams are renowned for integrating seamlessly alongside our clients, providing effective support, delivering strategic insight and innovative approaches to all aspects of CNS drug development, from transitional science through to registration and medical affairs, worldwide.
tranScrip has a proven track record of achievements that include:
Designing and delivering of cross-functional CNS & pain programmes.
Defining and validating regulatory strategy for a small manufacturer developing novel formulations and delivery routes for established opioid products.
Serving as the “one-stop shop” drug development organisation for small biotech companies.
Providing clinical leadership and cross-functional team to meet demanding timelines in taking a novel, first-in class compound through to Proof of Concept in Parkinson’s disease.
Interpreting ‘diﬃcult’ outcomes in clinical trials and steering development strategies.
Identifying and validating development strategy for a promising, but previously inappropriately targeted therapeutic for neuropathic pain.
Fielding multi-functional submission teams to support MAAs and NDAs.
Liaising between a small biotech and EU regulatory agencies in defining requirements for EU approval of US-approved addiction product.
Providing expert CNS support for a variety of development activities.
Helping a large pharma company bridge expertise shortfalls across the CNS area by providing clinical expertise and strategic guidance.
Providing tailored support for product launches and lifecycle activities.
Design of a post-licensing clinical programme for a novel chronic pain product. Medical oversight of clinical studies.