NIBSC - Scientific and regulatory advice

Scientific and regulatory advice

of the key objectives of NIBSC and of the wider Medicines and Healthcare Products Regulatory Agency (MHRA) is to support greater access to safe and effective medicinal products and medical devices.

Our senior scientists make a vital contribution to national and international regulatory and policy-making bodies, giving advice about biological medicines to ensure that public health decisions are made on the basis of the best possible evidence. We also provide advice to manufacturers and developers of biological medicines.

Advice to manufacturers and developers of biological medicines

The timely introduction of innovative products benefits both patients and the public. To support the innovation process, NIBSC offers scientific advice and training on the characterisation, standardisation and control of biological medicines to those involved in their development, testing and monitoring.

Our experience is that the earlier in the developmental process that issues are considered, the better the outcome in terms of safe and effective products. We therefore encourage those who are developing innovative biological medicines to seek our advice as early as possible.

In many cases, informal advice can be provided free of charge. If we need to make a charge, for example for formal or more complex advice, we will discuss this with you.

Get scientific advice from NIBSC

You can access advice from NIBSC either:
- directly from one of NIBSC’s scientific groups
-via the agency’s Innovation Office
- by emailing business@nibsc.org with the following information:
- name
- organisation
- email address
- telephone
- summary of enquiry

Alternatively, if you are already in contact with a NIBSC scientist, you can discuss the advice that you need with them.