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 infectious disease teams are renowned for integrating seamlessly alongside our clients, providing effective support, delivering strategic insight and innovative approaches to all aspects of anti-infective 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 large, complex, cross-functional ID programmes.
Providing pre-clinical, medical and operational support, taking a Gram-negative antibiotic from Phase 1 to Phase 3.
Serving as the "one-stop shop" drug development organisation for small biotech companies.
Supporting clinical, regulatory, drug safety, and commercial needs for a novel antifungal from registration to launch.
Interpreting ‘difficult’ outcomes in clinical trials and steering discussions with the regulatory authorities.
Unravelling a complex safety signal and achieving successful EU registration for a novel Gram-positive antibiotic.
Fielding multi-functional submission teams to author and deliver MAAs and NDAs.
Our teams' have supported >10 NDAs and MAAs for antibacterials and antifungals, with 100% success rate.
Providing commercial strategy from early development to product launch, across multiple programmes.
Due diligence for an antibiotic asset acquisition. Evaluation of strategic options and valuations of antibacterial portfolio, leading to successful partnering.
Supporting various peri-launch activities, including tailored training programmes, KOL identification and engagement, medical advisory, etc.
Pre- and post-launch medical and microbiology support to a C. difficile infection antibiotic.