Outsourcing
We routinely work with a large number of analytical contract houses, in the UK in Europe and in North America. These vary enormously in terms of size of organization, techniques available, infra structure and quality system and cost structure. Based upon the actual requirements of the sponsor's projects we will identify one or more potential contract laboratories capable of performing the service.
We will set up initial meetings with the CRO(s) to scope the project, timelines and costs and conduct audits as required.
Once the go ahead has been given, we will ensure that method transfer is competently planned and executed (if appropriate we can prepare the protocols for the transfer). We will ensure that validation/verification is facilitated and performed in a technically and compliant manner.
Your project can be actively managed throughout its duration by ABPharm, using e-mail, conference calls, and, if necessary, face to face meetings.
We will ensure all analytical work is carried out to cGMP and if required we can compile summary reports appropriate for regulatory submissions.