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Scientific Advice

Why and when is it needed?

We at CambReg are proud of the extent of our scientific and strategic knowledge. However, there are times when we recommend clients to approach the regulators for more formal advice

Such Scientific Advice (SA) can be obtained at any stage of drug development from early stage studies, through to licence submission and post-approval activities (e.g. addition of a new indication).  It can also be obtained for Orphan Drug development (Protocol Assistance).

The main purpose of SA is to get prospective advice before studies are started, or even designed, thus ensuring data generated are exactly what the regulators are looking for.  This is particularly true when there are no EU guidelines (or insufficient relevant detail in existing guidelines) covering the area of concern and/or when the company chooses to deviate from the available guidance in its development plan.

How to seek Scientific advice

In the EU, Scientific Advice can be obtained nationally from the Member State Health Authorities or centrally from the EMA. The agency you chose will depend on your intended submission route and target countries.

Although there is no formal legislation that specifically covers this area (and thus advice given is not legally binding), the EMA website details the formal procedure you need to follow (1).  Similarly, the National Agencies have also issued their own guidance (e.g. the MHRA (2)).

There is also scope to obtain parallel EU /US Scientific Advice (EMA / FDA) which is of value for global development programmes.

Our Services

We can:

  • Provide pre-SA strategic advice and craft the questions to be asked
  • Supply experts to support your application (pre-clinical, quality, medical etc)
  • Liaise with Health Authorities (from pre-submission activities to post-SA follow-up)
  • Prepare the supporting documentation and arguments in the correct format
  • Help you prepare for meetings with the regulators
  • Provide expert opinion on how the SA is to be interpreted

Our experience can help you

CambReg’s experience in this area is second to none.  We have approaching a 100 years of combined experience within the core CambReg team plus hundreds of additional years if our large expert panel is included. Our seasoned professional staff know the best approach to getting the maximum use from the regulator’s Scientific Advice services.

References

  1. EMA website: http://www.hma.eu/index.htmlhttp://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000049.jsp&mid=WC0b01ac05800229b9
  2. MHRA website: http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Informationforlicenceapplicants/Otherusefulservicesandinformation/Scientificadviceforlicenceapplicants/index.htm