Service Description
Complex Research and Medical Affairs activity require a multitude of
rigorous analyses and submission reports, often to meet tight timelines.
Independent expert opinion brings additional value to such reports, such
as Periodic Safety Update Reports, Clinical Expert Reports, and regulatory
submissions commercial.
Our approach has, since 1994, been to provide high quality, independent,
approachable experts to provide these analyses to an agreed budget, on
time, meeting the clients specifications exactly.
Our methodology is adaptable to the client's needs by project and is
therefore hard to generalise. However, common to each project is a intense
period of briefing and two-way communication during the project initiation,
repeated checking with the client sponsor that the business output meets
needs and then close cooperation with the client until the project is
completed and the client is delighted.
Case Study
- Our client, a UK affiliate OTC division of a
European and international pharmaceutical company, wanted to gain a
Pharmacy license for one of its ethical product range. The submission
had to be processed and with the Regulatory Authorities by 31 December.
- Unfortunately, the OTC division had limited
internal resource, especially expert medical support and he ethical
division were unable to help. Consequently, the client outsourced the
submission to our regulatory and medical technical consultancy group.
A completed draft submission was prepared in close co-operation with
the client by 6 December enabling submission by 20 December.
- An interim, independent external medical assessment
provided clear motivation to the regulatory team to continue with the
project despite some earlier concerns. A submission was made possible
despite the lack of internal medical support and with a considerable
saving being made on internal regulatory activity; additionally the
regulatory team were able to guarantee they spent Christmas with their
families!
- Our clients opinion:
We had an extremely tight deadline and all
parties worked exceptionally well to complete the task on time. The
justification report was well laid out and easy to follow. It was
thorough and contained all the necessary details. This was used to
prepare the expert statements. I would not hesitate to recommend this
collaboration in the future and it was a pleasure working with the
personnel involved.
DM, Regulatory Affairs, Swiss Pharmaceutical
Co.
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