Regulatory & PV Support Services
We also provide regulatory and PV services for our clients, which can be tailored to suit individual companies’ needs.
Our regulatory support includes Marketing Authorisation sourcing, MA transfer, ongoing licencing support, CMC authoring and preparation of type I and type II variations and submission to EMA and national health authorities such as the MHRA and HPRA.
Our team can undertake client PV support requirements or perform specific tasks where the client may have a lack of resources. We are able to offer a range of services, including RMPs, collation and follow-up on ADRs, literature searches, reporting to HAs, signal detection and preparation and submission of PSURs.
We can also provide local in-country PV representative and LCPPV in the UK.
• For our UK PV services we support clients in having access to the reports of suspected adverse reactions referred to in regulation 187 of the HMRs and the PSMF for UK authorised products.
• The LCPPV will also be able to facilitate responses to pharmacovigilance queries raised by the MHRA, including via inspections.
