PSR: the Orphan Drug Expert
As a leading expert in Orphan drug development, PSR provides the essential ingredients necessary to help our clients through the logistical and regulatory hurdles which are the hallmark of development programs for rare diseases. Our services span the planning, design and implementation of the program providing a one-stop-shop from start to finish.
Not only do we provide specialist clinical CRO services, we also offer a range of consultancy services to assist with, for example:
- Regulatory advice on a range of issues.
- Obtaining orphan designation (sometimes called orphan drug status) from the EMA (EMEA) in Europe and the FDA in the USA.
- Facilitating protocol assistance (or scientific advice) at the SAWG.
- Interaction with the COMP.
- Advice on the design of clinical development plans.
- Design of appropriate clinical trials.
- Paediatric investigation plans (PIPs).
- Interaction with the PDCO.
- SME status support.
- Ethical / practical considerations (e.g. consent / assent strategy in paediatric studies).
- Market access / reimbursement strategy.
- Legal / IP issues.
In addition to traditional consultancy services, PSR offers OrphanIQTM, a quick and easy way to ask a short question without the need for setting up time-consuming agreements and contracts.