A global pharmaceutical client required delivery of an urgent global site transfer of its affected product portfolio following the sale of one of its key manufacturing sites to a third party.
A hard deadline due to the third party taking over the site and a legal change to the Manufacturing Authorisation, meant a non-flexible 3 month timeline from brief to implementation had to be met.
Rapid project team assembly (12 FTEs) was necessary including onboarding to client project, systems and processes.
Regulink deployed industry leading proprietary onboarding strategies and processes developed specifically for clients with urgent resource requirements. This significantly reduced the onboarding time typical with outsourcing companies.
Overall PM responsibilities were set up to work directly with the client internal team including direct reporting to the senior leadership team.
This approach required E2E management including strategy, data collection, CMC authoring, QC, upload to client eDMS and RIM notification, eCTD publishing, Health Authority submission and tracking.
A complete set of procedural and national NeeS/ eCTD submissions were made and approved RFT based on a highly detailed internally developed submission plan. The site transfer completed on schedule with no outstanding regulatory non-compliances.
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Whether it be a special regulatory project, intelligence, strategy or support with the essential life cycle management aspects, Regulink provides solutions that have delivered successful and cost-effective outcomes time after time. We are proud of the range and quality of services that we can provide, evidenced by the long term working partnerships we have established with our varied client list. Although not an exhaustive list, the main areas of our expertise and services are shown below:
Regulink provides pharmacovigilance services tailored to support your business needs. Our UK-based in-house QPPV has extensive experience from working as an EU and UK QPPV, with demonstrated leadership and management of large PV projects and teams of PV officers. We understand that all projects and clients are unique, so as with Regulatory Affairs, we offer a fully flexible service and work closely throughout to ensure your requirements are always met. The main expertise and services provided are shown below:
Regulink was established by industry veterans, Stuart Reed and Sunil Singh, in 2014, following lengthy independent careers within industry and consultancy organisations. With recent changes to the consulting landscape, Regulink has rapidly grown to take on core partners with highly valuable and niche experience, as well as expanding its consulting partner network to be able to cater for its clients of all sizes. Regulink now offers consulting and other services in UK, Europe, US and Australia, supported by local expertise, and continues to grow, whilst always providing the flexible and scalable services that industry needs.
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Regulink was established by industry veterans, Stuart Reed and Sunil Singh, in 2014, following lengthy independent careers within industry and consultancy organisations. With recent changes to the consulting landscape, Regulink has rapidly grown to take on core partners with highly valuable and niche experience, as well as expanding its consulting partner network to be able to cater for its clients of all sizes. Regulink now offers consulting and other services in UK, Europe, US and Australia, supported by local expertise, and continues to grow, whilst always providing the flexible and scalable services that industry needs.”
Regulink provides specialist consulting and support services in all areas of regulatory affairs, CMC, pharmacovigilance and project/ programme management to the life sciences industry. We have a broad team with relevant experience in the key sectors of this diverse industry.