Arriello Group Services

Regulatory Affairs & Registrations
Strategy to submission

GMP Audits
If you are looking to enter a new market and require GMP Certification, then we can help.
Our team of expert auditors have many years experience in assessing manufacturing sites,
providing Gap Analysis and then working with you to fill those gaps. We will help you to be
ready for an actual FDA or EU GMP audit.

EU, US, CIS & Middle East Registration Support
We focus on registering your products where you need it. Our in-house team will manage
your registration in line with the required regulatory processes. Our team has many years
experience in registrations and regulatory affairs, ranging from early stage high level
registration strategy consultancy, scientific advice with agencies in EU, CIS and the Middle
East. And finally, we are able to run your procedure and then maintain it (Variations,
Renewals) once the MA has been granted.

Arriello MAA/MAH Service
We register under our own name in Europe and have a number of ongoing registrations. Do
you need an MAA for countries where you have no presence or until you find a buyer? We
offer a full MAA service. With a fully compliant Pharmacovigilance system, we are able to offer
a safe service and allow you to maximise your market potential. We can be the Marketing
Authorisation Holder (MAH) holder until you are ready to transfer.

Readability Testing
No company has tested more Patient Information Leaflets (PILs) in as many countries as us.
From national testing in UK, Ireland, Romania, Belgium, France, Spain, Portugal, Czech
Republic, through to English testing for any EU registration, we will assess your portfolio free
of charge and give you the most experienced and sensible solution.

eCTD Publishing
We offer a full dossier review and publishing service. We can assess old dossiers and provide
a Gap Analysis. We will then update your dossier to be compliant. We use the latest eCTD
software tools in-house to prepare and convert your dossiers in eCTD or NeeS formats.

Arriello Group, Bracetown Business Park, Clonee, Dublin 15, Ireland
EU Offices: Dublin +353 125 440 33 | Prague: +420 222 523 941 | Bucharest: +40 312 210 991
E-mail: info@arriello.com | Website: www.arriello.com

Translation Services
A Truly Integrated Approach

Complete Translation Knowledge
We specialize in translating Life Science text, from pharmaceutical text (medical, legal,
marketing) to technical text for medical devices and clinical trial materials. We provide a
solution for your language needs by having the most qualified Translation Project Managers
managing a team of the most industry-specific proficient linguists. We understand that poor
terminology management means inconsistency. That is why we use the best tools to manage
your content so that we consistently translate the same terms, the same way, every time.

Life Science Experience
We are a full service provider to Life Science companies. Translation is not something that can
be seen as a separate activity – it is an integral part of the regulatory process. We offer what a
broad based translation agency or individual linguists cannot – a true understanding of
regulatory affairs, pharmacovigilance and artwork, project managed. We have in-house
expertise in all of these areas and we integrate these departments to give a seamless
translation package.

Compliant with EN-15038
Our services are offered in compliance with the European standard EN-15038 to ensure that
we provide a high standard service offering:

• The exclusive use of qualified, certified translators
• Translators who only translate only into their native language
• Proofreading of each translation by a second professional translator skilled in
the respective subject

Working to this standard ensures the quality and reliability of the work we produce.

Artwork Integration & DTP
Your artwork text is likely to be in many languages. How do you ensure that you get the
artwork to be compliant with local requirements, and meet your manufacturing requirements
whilst ensuring that the layout is not affected? It is not easy.

Arriello solves this problem. All of our artwork is managed with Translation Integration –
which means that every time we create artwork or update translated artwork, we use our
linguistic skills to ensure all these competing factors are achieved. We take into account the
blue box requirements, your printing limitations and ensure that we edit as professionally as
we translate.


Medical Writing
Putting the Science into Writing

Dossier Preparation/Conversion - NtA to eCTD
Our expert medical writers are able to make your dossier “Registration Ready” for whichever
market you are going in to. We can take an old format dossier such as Notice to Applicants
(NtA), provide gap analysis and then align it to the latest standards. And with us using
industry standard eCTD software for electronic submissions, we offer the complete solution.

Non Clinical & Clinical Overviews
We understand the importance of getting Non/Clinical and Clinical Overviews correct. Our
writers have the experience to write these in the most effective manner. We have invested in
access to databases such as Embase, allowing us to provide you with a wide and deep range of
articles to support this activity. Furthermore, we have a dedicated network of experts for any
national literature searching. Our medical writers are experienced in most therapeutic
categories, allowing us to cover nearly any kind of clinical and non clinical requirement.

CTA & IMPD
To avoid delays in gaining regulatory approval, it is imperative to be very familiar with the
requirements of a clinical trial application (CTA). This includes such requirements as those for
pharmaceutical quality, as described in the investigational medicinal product dossier (IMPD).
Our team ensures that by analysis of the submission package, we ensure being in compliance
with ICH guidelines and international regulations.

Paediatric Investigation Plans (PIPs & PIP Waivers)
We are able to provide the highest level of experience in the design and writing of Paediatric
Investigation Plans. Moreover, we can assist in the justification for a PIP Waiver, and have
strong practical experience in a range of different scenarios.

Bioequivalence Studies/Waivers
BE Study protocol design is very important for your future registration and approval, and it is
necessary for you to pick the right expert to compile it. We work alongside trusted
laboratories that conduct BE Studies and we provide the reporting capability – a complete
solution. Be assured that we can help you with protocol design for any market, and our highly
experienced scientific writing team will deliver the best results.


Pharmacovigilance
You’re Safe in Our Hands

Full PV System
We have our own internal PV system to allow you the ability to use it either independently to
support your activities or as part of the Arriello MAH service. Our PV system has been built
from the bottom up, working with distinguished external experts in the industry. With a highly
regarded QPPV and Deputy QP team, we will give you the peace of mind that your safety is in
our hands.

XEVMPD Support
We provide a complete XEVMPD service by offering data collection, data entry and quality
control by a highly reputed group of pharmacists and doctors. Moreover, if required we will
work remotely in your own XEVMPD system. Our QP and Deputy QP team have gained the
necessary qualifications to use the EMA EVWEB Trader tool and have the applied
understanding of the most important commercial packages that are on the market.

EU QP and Deputy QP - In-House
We have invested in having experienced QP and Deputy QP’s, in-house. Moreover, we have
invested in key people with many years international experience. We continually invest in
their education to remain at the forefront of understanding guidelines. Our PV team works
closely with our in-house regulatory affairs team to ensure complete compliance and
understanding.

SOP/QMS Preparation
We have built our own PV system with detailed SOPs and an auditable QMS system. Our
experience in this area also transfers to you. If you are looking to build your own PV system,
require your system to be reviewed or are expecting an audit, we can help. We can prepare or
review your SOPs and QMS to ensure that you have the utmost confidence in your own
system.

Maintenance Documents - PSURs, RMPs, REMS
We have extensive experience in preparing high quality maintenance documentation such as
DSURs, PSURs, RMPs, and REMS in order to ensure you are compliant. We have access to a
wide variety of databases and vast practical experience, enabling us to provide the most
accurate literature searching to support such activities.


XEVMPD Support
Managing your Medicinal Information

Our Approach
Headed by our EUQP and Deputy EUQP, we are in a strong position to offer you a bespoke
XEVMPD service. We have been closely following the developments of XEVMPD and have put
in place a management team with XEVMPD experience.

We are software independent. If you have already purchased software to handle XEVMPD
submissions, then we can work remotely in your system, as we would if we were using
EVWEB. It is your choice, EVWEB (free tool) or the software you purchased (vendor tool).
We can work with both.

We have developed a process to make sure that you will meet EMA requirements, on time
and to budget. We divide this submission into two different tasks:
1) XEVMPD Administration
2) Processing of Authorised Products

Process
Our quality system applies its standards to this new area. Data Entry & Quality Control are the
two key elements of our XEVMPD management process. The quality of personnel handling
this process is key. Our QC Team, led by Doctors and Pharmacists, carefully selects the Data
Entry team and manages it in accordance with our Quality Management System.

How will Arriello deliver data to EVWEB?
We have a dual approach, depending on your requirements. We are certified to use the EMA
Web Trader tool. Moreover, we are ready to work with commercial software as needed.
Therefore, we offer two service models:

a. EVWEB Management - this service includes standard Data Entry and QC, using the
free EMA WEBTrader tool. This approach is ideal for clients with a small number of
licenses.

b. Software Management - as above, but utilising a commercial tool. This allows
clients to have better Life Cycle Management, and takes into consideration the
forthcoming ISO standard, coming into effect in 2015. Our Project Managers can
work with your choice of software, remotely or in-house.

So why Arriello?
We:
- Have leading industry experience.
- Have an experienced software team.
- Are ready for July 2012 and 2015 and we are thinking beyond!


Medical Devices
Assuring Market Entry and Global Compliance

European Authorized Representative
We can be your European Community Representative. It means that we will be responsible to
the EU competent authorities to ensure that you, the manufacturer, fulfil all duties and
responsibilities as stipulated by the directives. We will take care of all necessary reporting,
registration and communication with European authorities and bodies.

Audit, SOP/QMS Preparation
We can prepare the complete quality management system (QMS) in compliance with ISO
13485 / 21 CFR / Canadian Medical Devices Regulations including customized Standard
Operating Procedures (SOPs) for Clean Rooms manufacture, sterilization and Medical Device
Vigilance system and Incidents / Near Incidents / reporting procedures, allowing you faster
access to market.

Document Preparation for CE-Mark, 510 (k) Clearance
A Technical File / Design Dossier is required for all products falling under one of the three
medical device directives, including low risk Class I, custom made devices and procedure
packs. We will help you to comply with the necessary legislation and assist in ensuring that
your QMS / Technical File / Design Dossier is ready for review by a Notified Body (as and when
necessary) or the local Competent Authority in Europe / USA / Canada / other countries.

RMP Guidance Compliant with ISO 14971
We can ensure that your medical devices are in full compliance with ISO 14971 (Medical
devices — Application of risk management to medical devices). This includes DFMEA, PFMEA,
Hazard Analysis, UFMEA.

A 510(k) / PMA is required for all products to be sold in the USA to comply with 21 CFR. We
will ensure that your QMS is in compliance with GMP as per 21 CFR, part 820.

A Canadian Medical Device License is required for all products to be sold in Canada. Arriello
will ensure your QMS is certified by a CMDCAS recognized registrar.

We can provide registration in almost every country of the world as required by local
competent authorities.


Medical Devices
Assuring Market Entry and Global Compliance

Medical Device Vigilance
We can provide consultancy services in PMS (Post-Marketing Surveillance) and vigilance for
devices, be they device-alone or drug device combination products, as part of our Medical
Device / Pharmacovigilance service. We also prepare Periodic Vigilance Reports: Complete and
Submit Periodic Summary / Trend Reports to any National Competent Authority.

Monitoring of Standards
We can research the standards applicable to your products and monitor these standards to
ensure that you comply with them. These include the most important standards such as those
being issued by the United States - American Society for Testing and Materials International
Organization for Standardization; European Union - European Committee for Standardisation.

Local Support
Our in-house of experts together with our network of high trusted partners allow us to offer a
wide coverage and reach countries other companies can’t with out assistance, you can handle
issues at local level in countries in which you don’t have physical presence!

Labeling
We can create complete labeling support for your medical devices and ensure you will be fully
compliant with all required regulations including EU, USA and Canada. Moreover we can
review your current labeling to ensure continuous compliance.

Research and Development
We can assist you with your new product development, from initial set up to final approval
from the relevant authority. We help you find and understand the requirements and to create
all the supporting documentation for product development, including DHF and DMR.

Registrations
A Technical File / Design Dossier is required for all products falling under one of the three
Medical Device Directives, including low risk Class I, custom made devices and procedure
packs. We provide registration support for Medical Device companies.

We will assist you to comply with the necessary legislation, ensuring that your documentation
is ready for review by a Notified Body (as and when necessary) or the local Competent
Authority in Europe / USA / Canada or other countries.


Business Development
Maximizing your Sales & Market Opportunities

In/Out Licensing Support
Through our extensive business network we select the companies with the strongest sales
force in each country, and secure the maximum supply for your product. Moreover, we will
design the best regulatory, business and pricing strategy for your dossier. We will help you to
get your product to new markets in the shortest amount of time.

Co-Development
We don’t just work with pharmaceutical companies; our network consists of manufacturers
and key R&D facilities. If you are looking to develop a product and looking for a legitimate
partner to do it with, then Arriello can provide all the necessary support.

Market Research
We provide a comprehensive and tailored market research service to clients. We can help
with identifying trends in markets, entry strategies and locate possible partners, just to name
a few. We operate in many markets so our research is as practical as it is academic.

Exports & Tender Support
We can export your pharmaceuticals internationally through partners. Our focus is in Europe,
CIS and the Middle East. Moreover, we can become your third party MAH and secure supply
by selling via:

• Marketing and distribution pharmaceutical companies
• Wholesalers and pharmacy chains in Europe, the Middle East and CIS
• Public Sector Tenders


Arriello Group is a well established service provider to the Life Science
industry covering Pharmaceuticals, Medical Devices, Cosmetics and Veterinary

We provide:
Regulatory Affairs and Registrations, Electronic Publishing, Medical
Device Support, Pharmaco/Medical Device Vigilance, Medical Writing,
Translation and Artwork support

We ensure you get your products to market and stay compliant

Our in-house expertise and trusted partners ensure that we have the right
resources to meet your project requirements

Professionalism, scalability and flexibility are our core principles

We have a client base of more than 200 companies across the globe ranging
from Originators, Generics and CRO’s

Arriello Group EU Offices: Dublin +353 125 440 33 Prague +420 222 523 941 Bucharest +40 312 210 991
Email: info@arriello.com Website: www.arriello.com
Head Quarters: Bracetown Business Park, Clonee, Dublin 15, Ireland

Arriello Group Services

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