tranScrip has extensive expertise in the infectious diseases area, encompassing antibacterials, antifungals and antivirals (including COVID-19). This includes both host and pathogen directed therapies as well as systemic, topical and inhaled agents. tranScrip has supported pharma and biotech companies across all phases of preclinical and clinical development, including microbiology, PK/PD, design and oversight of clinical programmes, regulatory strategy and agency interactions, MAA/NDA submissions, peri-launch medical affairs and commercial activities. tranScrip also supports in- and out-licensing, fund-raising and due diligence activities.
What we do
When there is a problem or gap, we can become your long-term partner and create a way to resolve the issue together.
Why we are different
Our infectious disease teams are renowned for integrating seamlessly with 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.
tranScrip has a 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.