Regulatory Affairs, Readability Testing, eCTD, PIM, PSUR, Literature searching, Clinical/Non-Clinical Overviews, QPPV, EUQP, Medi

By: Arriello  05/12/2011

Pharmaceutical Regulatory Affairs

Arriello has a team to provide EU Regulatory Affairs from our office in Prague, through to our Network of Excellence in all European countries.  We provide support for all submissions from National Procedures, Mutual Recognition Procedure (MRP), Decentralised Procedures (DP) or a Centralised Procedure (CP) and all relatred aspects.

Case Studies

Other products and services from Arriello


Electronic Common Technical Document :: Arriello

We are able to provide the complete dossier in eCTD or NeeS format using the most reputable software on the market. Arriello takes care of your eCTD conversions when you do not have time or resource. To see more details on the eCTD Structure.


User Test, Readability Test, Readability Testing, Patient Information Leaflets, Focus Tests, Focus Testing, PILs :: Arriello

From National Testing in Romania, Belgium, France, Spain, Portugal, Czech Republic, to name but a few through to English testing for the MHRA and EU registrations. Arriello will assess your portfolio free of charge and give you the most experienced.


ectd, medical writing, Modules 1-5 :: Arriello

We have a vast array of in-house expertise in Module 2.4 and Module 2.5, this is where we can ensure you meet your tight timelines. All of our Medical Writers are based in Europe and have the experience and diligence to ensure safe and accurate information. Arriello expert medical writers are able to make your dossier “Registration Ready”. Have Clinical and Non-Clincal Overviews to do.


Mutual Recognition Procedures, Decentralised Procedures, Centralised Procedures :: Arriello

With many years experience in the full registration process, ranging from registration consultancy and slot bookings through to National, MRP, DCP and CP registration in the EU & FDA submissions, we are your ideal, flexible partner. Arriello has an in-house team to manage your registration process.


Marketing Authorisation Holder Services, MA Transfer, MA Application :: Arriello

Do you need an MA holder for countries where you have no presence, until you find a buyer. EUQP and EVWEB Accreditation, we can hold your MA until you are ready to transfer. Is your marketing strategy duplicating filings.


Services :: Arriello

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 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. Arriello takes a Project Management approach to every service that we provide.