Drug development in many areas of internal medicine is thriving, with companies expanding their pipelines in cardiometabolic, auto-immune, women’s health or kidney diseases. Various rare but devastating conditions are also the focus of the industry, with a number of orphan drugs rapidly progressing through clinical development. tranScrip’s expertise covers small molecules as well as monoclonal antibodies, cell therapy, antisense oligo-nucleotides and gene therapy. We are helping our clients seize opportunities and meet their development goals by challenging the current clinical and regulatory paradigms.
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 internal medicine teams are renowned for integrating seamlessly with our clients. We provide effective support by delivering strategic insights and innovative approaches to all aspects of drug development, from translational science through to registration and medical affairs.
tranScrip has a track record of achievements that include
Designing and delivering large, complex, cross- functional programmes.
Creation and implementation of a global development strategy for gene therapy treatment of choroideremia.
Serving as the “one-stop shop” drug development organisation for small biotech companies.
Clinical and regulatory guidance and support for early phase cystic fibrosis trials.
Interpreting ‘diﬃcult’ outcomes in clinical trials and steering discussions with the regulatory authorities.
Discussions with EU national agency on a treatment for muscle wasting to gain agreement on a novel primary end point.
Fielding multi-functional submission teams to author and deliver MAAs and NDAs.
Supporting successful MAA and NDA submissions for a phosphate binder.
Providing management and oversight for drug safety and labelling needs.
Expert oversight of PSURs and leading EU SMPC harmonisation for a portfolio of products.
Developing and delivering tailored strategies for product launches.
Distance learning training programme for key personnel in an originator company to effectively defend against launch of biosimilar products.