Arriello - Regulatory, Safety, Language, Labelling
Arriello takes a Project Management approach to every service that we provide. We specialise in the Pharmaceutical sector. Our core aim is to get you to market and keep you there, in the quickest and most flexible manner possible, ensuring at all times that you remain compliant.
Our experience in this industry ranges from working with the smallest OTC companies through to the largest Generic and Originator companies across the world.
Our core beliefs are flexibility, experience and value - a new way of serving the Pharmaceutical industry.
Our four key areas of expertise are:
Regulatory Affairs:
- Module 1-5 eCTD preparation
- Local support (Module 1)
- Readability Testing of Patient Information leaflets (PILs)
- Clinical and Non Clinical Overviews
- Medical Writing
- SmPC (Summary of Product Characteristics) Harmonisation
- SmPC (Summary of Product Characteristics) Sourcing
- PSUR (Periodic Safety Update Reports) preparation
- EVWEB Certified
- Literature Searching
- Validated Database support
- EU QPPV/PVQP (EU Pharmacovigilance Qualified Person )
- Medical Translations
- Legal Translations
- Interpreters for meetings/conferences/seminars
- Certified Translations
- PIL Mock Up design
- Graphic design
- Blue Box Requirements
- Translation Integration
We do not stop there. Our relationships with service providers mean that not only do we provide key services directly to the industry, but we are also the first choice for many CRO's. Why? Because we have the ability to deliver bespoke services to the sector based upon our vast experience and our Network of Excellence.
Arriello - Regulatory, Safety, Language, Labelling - your flexible partner.
Latest news
The Arriello Group are pleased to announce the appointment of Romina Kohei as Head of the
Read more...The Arriello Group are pleased to announce the appointment of Jiri Sikac as EUQP & Head of the
Read more...
