Additional QP support for a small manufacturer of liquids, creams and ointments while their Trainee QP prepares to re-take the viva examination.
Final QP certification for a blockbuster product, in tablet form, with a complex supply chain and ultimately destined for several European Member States.
Independent assessment of the Quality Management Systems in place to support QP certification at a virtual site importing an investigational medicinal product into the EU.
Oversight for the process validation of a reformulated solid dosage form manufactured by a Contract Manufacturing Organisation (CMO) on behalf of an overseas client.
Additional external GMP/GDP audit resource for a major multi-national company, particularly for Phase I Clinical Trial Units and National distributors.
Providing additional resource for the Review and Approval of Product Quality Reviews (PQRs).