Global Pharmaceutical Regulatory Affairs

It’s not enough to simply understand regulatory requirements, you need to know how to efficiently navigate them. Get the expertise to meet both regulations and your objectives... faster, better, smarter.

arriello_regulatory affairs

How, when and where.
The smarter approach to Pharmaceutical Regulatory Affairs.

The decisions you make about pharmaceutical Regulatory Affairs can fuel your growth...or create unnecessary obstacles between you and your objectives.

Initially launching your drug in one country can speed up its launch in another, but it might potentially cap your pricing in other countries, or across an entire regulated market! That means successfully navigating regulatory requirements is more than simply following the rules...it’s about understanding the complexities and implications of Decentralised, Centralised and National Procedures, and developing the best strategy around them.

With over 35 years combined experience, Arriello has the in-house expertise to develop and execute that strategy worldwide across the EU, LATAM, MENA, CIS, and APAC regions.

It doesn’t matter if you’re a US-based biotech looking to reach specific or all markets, or you need guidance for OTC authorization. From preparing and maintaining dossiers to providing translation services, we make sure our clients can achieve their goals faster, better, smarter.

Comprehensive support for all your regulatory requirements.

 

Your Common Technical Document (CTD) dossier plays a critical role in bringing your drug to market.
When you partner with Arriello, you’ll gain comprehensive support for your CTD...whether that’s a pre-submission gap analysis or post-submission activity such as life cycle maintenance.

 

Support stages

CTD Pre-Submission Support

Through a comprehensive gap analysis and review, our experts can find and resolve technical issues and problems in advance, avoiding costly delays and deficiencies that allow us to publish your dossier faster, better, smarter.

CTD Submission

We don't just publish your dossier, we make sure we submit it to all relevant authorities, checking for reception, following up on progress and keeping you fully informed on your dossier's status.

CTD Post-Submission Support

Submitting your CTD is only part of reaching your goals and realizing continued success. We also follow up with all relevant authorities to ensure that any dossier deficiencies are corrected and your Marketing Authorization is granted as fast as possible.

CTD Pre-Submission Support

Set your CTD up for success with expert strategic guidance, and leverage over 35 combined years of experience in Regulatory Affairs. Explore the comprehensive services we provide, including…

Gap analysis
We’ll evaluate your dossier and pinpoint what’s missing - as well as the steps you should take to correct it.

Dossier updates
Your dossier is a living document- keep it updated with the information you need for successful submission.

GxP inspection support
From Good Manufacturing Practice (GMP) inspections to Good Distribution Process (GCP) inspections, we’ll provide the guidance you need for inspection approval.

WDA application support
Rely on Arriello to shorten your WDA application timeline so you quickly reach your target market.

Electronic Common Technical Dossier (eCTD) support
Remain ICH compliant, and tap into our expertise in submitting eCTDs.
Our comprehensive support includes readability and user testing (RUT), preparing all Module 1 documents, and providing expert overviews as well as artwork and labeling among other activities.

Arriello - Global Pharmaceutical Regulatory Affairs - Pre-submission acivities - Miluse Heryserova

Miluše Heryšerová
Senior Reg. Affairs Project Manager

Comprehensive support - Fast!

Pharmaceutical Company, UK

On the heels of a marketing authorization (MA) renewal procedure, this UK pharmaceutical company entered national phase management and required local support from the Czech Medicines Agency. Because the organization updated its product information, the company needed to translate English text to the Czech language for the summary of product characteristics (SmPC), patient information leaflet (PIL), and labeling and turned to the Arriello team for support.

CTD Submission

Submitting an eCTD is no longer an option...it’s a necessity. At Arriello, we’ll publish your eCTD and can convert older NtA or NeeS dossiers quickly and accurately.

To expedite the process, allow us to submit your dossier and follow up with the appropriate agencies until you’ve successfully received your Marketing Authorization (MA) approval.

When you partner with Arriello, we can also act as your…

Applicant or authorized representative
Let us handle all the administrative tasks of your application and communication with Authorities, and take the headache out of securing your MA.

Market Authorization Holder
If you lack a presence in your target market, let our team become an extension of your own organization. We’ll hold your Market Authorization and transfer it to you afterwards.

Arriello - Global Pharmaceutical Regulatory Affairs - Submission activities   Francisco Bertoli

Francisco Bertoli
Regulatory Affairs Project Manager

Delivering a full solution.

UK Pharmaceutical firm

The client had no prior experience in EU submissions and how to acquire marketing authorization (MA) in multiple member states. Needing guidance, research, and a regulatory strategy, Arriello created a Decentralized Procedure (DCP) regulatory strategy, and provided support for everything from analyzing medical literature research to giving advice on selecting the right API vendors.

CTD Post-Submission Support

Submitting your CTD is only part of reaching your goals and realizing continued success. Tap into Arriello’s continued support, such as…

National phase management
Gain targeted support for navigating individual countries’ pharmaceutical Regulatory Affairs requirements.

Translation
Let us connect your organization to the linguistic expertise you need to translate your texts into the local languages of your target markets.

Market Authorization Transfer (MAT) support
When it’s time to transfer your MA, we’ll walk you through the process...step by step.

Product whole life-cycle maintenance
Your dossier undergoes constant changes. Rely on Arriello for renewals, extensions, and variations to your CTD.

Arriello - Global Pharmaceutical Regulatory Affairs - Post submission activities   Maria Bertoli

Maria-Mercedes Bertoli
Regulatory Affairs Director

Current or future Regulatory Affairs requirements?
Find out how a faster, better, smarter strategy can meet them.

Let our Regulatory experts advise, plan and deliver the perfect solution for your needs.