The formation of the Company is an important step in the growth of Regulis and is part of our Brexit-related plans.
The outcome of Brexit remains uncertain and there are various possible scenarios for the future relationship between the UK and the EU-27 that will, to a greater or lesser degree, affect pharmaceutical and medical device regulations. The most severe case is that the UK leave the EU on 29th March 2019 without a deal. In this case, the UK will become a third country.
Post-Brexit Regulis will continue to provide expert EU regulatory affairs, pharmacovigilance and quality assurance consultancy to companies. The formation of Regulis Consulting Europe Ltd. will ensure we can continue to provide comprehensive services to all our existing and future clients. These services include but not limited to:
- Acting as Sponsor for an EU Orphan Drug Application and preparation of the application.
- Acting as Applicant for an EU Marketing Authorisation Application via the Centralised, Decentralised, Mutual Recognition or National procedures and preparation, publishing and submission of such applications.
- Acting as Legal Representative for a Clinical Trial in the EU and preparation of Clinical Trial and Ethics Committee applications.
Devices registration and vigilance
- Full support for EU CE marking and lifecycle support
- Acting as EU Authorised Representative
- EU QPPV provision
- EU PSMF provision
- EU country-based LPPV provision
- Full post-marketing and clinical trial pharmacovigilance services
- QPPV and Responsible Person provision
- Obtaining national Manufacturing, Importation and Distribution licences.
We will also be able to support companies to meet any “new” UK rules and any National UK registrations that are required in the future.