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?
Working as long-term partners, our respiratory teams integrate seamlessly with our clients. We provide effective support by delivering strategic insights and innovative approaches to all aspects of respiratory drug development, from translational 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 respiratory programmes.
Creation and implementation of development strategy for a monoclonal antibody for COPD.
Serving as the “one-stop shop” drug development organisation for small biotech companies.
Design, implementation and medical oversight for a Phase III asthma study of a CRTH2 antagonist.
Interpreting ‘diﬃcult’ outcomes in clinical trials and steering discussions with the regulatory authorities.
Achieving additional indication for an inhaled COPD product.
Fielding multi-functional submission teams to author and deliver MAAs and NDAs.
Preparation and regulatory defence of an MAA for an inhaled anticholinergic in COPD.
Commercial evaluation of novel approaches, including TPP and pricing assessments.
Evaluation of food allergy products for US and EU markets. Price point testing and discussions with reimbursement bodies.
Strategic clinical and commercial guidance for respiratory devices.
Expert support for development of inhalation devices for various respiratory indications.