Circuit Medical
Circle Shape
Bottom Left Shape
Bottom Right Shape

Strategic Pre-Approval Access Planning

Access to essential unlicensed medicines when no other options are available can save or transform lives. These services are one of the most valuable that Medical Affairs provides.


About This Service

Pre-approval access may be referred to by other names such as expanded access programs, compassionate-use programmes, named patient use, early access to medicines etc.

Pre-approval access enables vital use of unlicensed medicinal products for diseases where there are few/no treatment options and where patients suffer from serious or life threatening conditions.

Patients in these programmes then transfer onto commercial supply as soon as the drug is commercially available/according to regulatory requirements.

Circuit Medical can support your organisation with these programmes.

Service Shape
Left Shape
Right Shape

Where We Can Support You


Develop strategic ambition and guardrails to manage programme risks


Develop eligibility criteria


Help build your pre-approval access forecast and support supply and distribution planning.


Develop/Evaluate the bioethical rationale for pre-approval access.


Plan to include post-approval risk mitigation proposals.


Build an evidence generation plan through data collected via a pre-approval access programme.


Define and collect metrics to support analysis and evaluations of your programmes.

More On This Service

Pre-Approval Access brings Medical Affairs closer to patients and care givers

Modern pre-approval access programmes that encompass innovation, robust bioethical foundations and data generation methods can bring patients many benefits quickly and directly.

DNA Shape

Why Choose Circuit Medical

We are relentless in our pursuit to help take your Medical Affairs delivery to a new level.  Click on Circuit Medical Consulting to find out how.

Our Value Shape