Real Experts, Real Results
The majority of our work is based around the lifecycle of human medicinal products in Europe, including Advanced Therapy Medicinal Products (ATMPs), New Chemical Entities (NCEs) and known drug substances. We also have in-house expertise to support medical devices and related combination products.
In terms of medicinal products, we can provide EU expert contributors to support products based on small molecules and products of biotechnology. These span from simple synthetic molecules right through to ATMPs based on stem cell or DNA technologies.
Please scroll down to the orange icons below to expand to the individual general services in each sector.
JAN 2021 – BREXIT SPECIFIC SERVICES: We can help mitigate the impact of Brexit for our clients. We continue to have a working office based in UK, we are up and running on the new MHRA portal for submissions, we have a seat at the table supporting the changes to MHRA systems and guidances, and we offer the following specific UK services.
- Conversion of centralised Marketing Authorisations to UK product licences
- Acting as the local UK PV contact for MHRA
- Transfer of MAs to a UK based MAH
- Review of regulatory documents for suitability for submission to UK
- Local submission of documents to MHRA
- Adaptation of Annexes to local needs
- Alignment of abbreviated prescribing information
- Alignment of updated leaflets
- Alignment of packaging
- Review of local marketing and medical material from regulatory perspective
- Upload of Prescribing Information to local database: eMC
- Liaison with MHRA for any issue management situations, e.g. an urgent safety issue/DHCP or quality defect/recall
- Any other ad hoc activities upon request
Importantly, we can speak to the benefit of our experience. Requirements are rapidly evolving and Real Regulatory is already working to minimise the resulting disruption to our clients, looking after their needs in Great Britain and Northern Ireland. Please allow us to help you. We are ready for anything.
Our services cover the full lifecycle of these products from proof of concept right through to product withdrawal.
Real Regulatory takes pride in the breadth of our capabilities and our success in working with clients whose needs may be broad ranging. Our extensive panel of external experts provide individual country, language and legislative expertise to complement our internal resources.