Case Studies

A certificate of suitability to the monograph of the European Pharmacopoeia (CEP) was required for a client's API.

A request from a key client for urgent senior CMC support for its US marketing authorisation submissions, with a pre-requisite for analytical method, verification and validation expertise, was successfully met by Regulink.

A client required urgent CMC team management following a departmental restructuring which evolved into a 5 year assignment.

A focus on some successful "switches" made to the legal classifications for certain well known medicines, now commonplace in the UK consumer healthcare market.

A client required user testing of its Package Leaflet (PL) in order to gain the MA and subsequently roll out a 'house style template' for future "bridging" of its other PLs for its existing and pending MA portfolio.

Regulink were asked to provide interim 0.5 FTE support to a pharma client, due to staff shortage at its UK & IE affiliate. Regulink was well placed to provide the necessary market experience and seamlessly onboard into the client role whilst the client recruited a replacement permanent affiliate lead.

One of our larger pharma clients sought a full compliance review and resulting remediation of 5 of their more important Type II DMFs.

A global pharmaceutical client required urgent implementation, management and delivery of a Brexit project, to prepare its Organisation and mitigate the impact of the withdrawal of the UK…