Regulatory Affairs & RegistrationsStrategy to submissionGMP AuditsIf you are looking to enter a new market and require GMP ...
Translation ServicesA Truly Integrated ApproachComplete Translation KnowledgeWe specialize in translating Life Science tex...
Medical WritingPutting the Science into WritingDossier Preparation/Conversion - NtA to eCTDOur expert medical writers are ...
PharmacovigilanceYou’re Safe in Our HandsFull PV SystemWe have our own internal PV system to allow you the ability to use ...
XEVMPD SupportManaging your Medicinal InformationOur ApproachHeaded by our EUQP and Deputy EUQP, we are in a strong positi...
Medical DevicesAssuring Market Entry and Global ComplianceEuropean Authorized RepresentativeWe can be your European Commun...
Medical DevicesAssuring Market Entry and Global ComplianceMedical Device VigilanceWe can provide consultancy services in P...
Business DevelopmentMaximizing your Sales & Market OpportunitiesIn/Out Licensing SupportThrough our extensive business net...
Arriello Group is a well established service provider to the Life Science      industry covering Pharmaceuticals, Medical ...
Arriello Group Services
Arriello Group Services
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Arriello Group Services

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

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Arriello Group Services

  1. 1. Regulatory Affairs & RegistrationsStrategy to submissionGMP AuditsIf 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 beready for an actual FDA or EU GMP audit.EU, US, CIS & Middle East Registration SupportWe focus on registering your products where you need it. Our in-house team will manageyour registration in line with the required regulatory processes. Our team has many yearsexperience in registrations and regulatory affairs, ranging from early stage high levelregistration strategy consultancy, scientific advice with agencies in EU, CIS and the MiddleEast. And finally, we are able to run your procedure and then maintain it (Variations,Renewals) once the MA has been granted.Arriello MAA/MAH ServiceWe register under our own name in Europe and have a number of ongoing registrations. Doyou need an MAA for countries where you have no presence or until you find a buyer? Weoffer a full MAA service. With a fully compliant Pharmacovigilance system, we are able to offera safe service and allow you to maximise your market potential. We can be the MarketingAuthorisation Holder (MAH) holder until you are ready to transfer.Readability TestingNo 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, CzechRepublic, through to English testing for any EU registration, we will assess your portfolio freeof charge and give you the most experienced and sensible solution.eCTD PublishingWe offer a full dossier review and publishing service. We can assess old dossiers and providea Gap Analysis. We will then update your dossier to be compliant. We use the latest eCTDsoftware 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
  2. 2. Translation ServicesA Truly Integrated ApproachComplete Translation KnowledgeWe specialize in translating Life Science text, from pharmaceutical text (medical, legal,marketing) to technical text for medical devices and clinical trial materials. We provide asolution for your language needs by having the most qualified Translation Project Managersmanaging a team of the most industry-specific proficient linguists. We understand that poorterminology management means inconsistency. That is why we use the best tools to manageyour content so that we consistently translate the same terms, the same way, every time.Life Science ExperienceWe are a full service provider to Life Science companies. Translation is not something that canbe seen as a separate activity – it is an integral part of the regulatory process. We offer what abroad based translation agency or individual linguists cannot – a true understanding ofregulatory affairs, pharmacovigilance and artwork, project managed. We have in-houseexpertise in all of these areas and we integrate these departments to give a seamlesstranslation package.Compliant with EN-15038Our services are offered in compliance with the European standard EN-15038 to ensure thatwe 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 subjectWorking to this standard ensures the quality and reliability of the work we produce.Artwork Integration & DTPYour artwork text is likely to be in many languages. How do you ensure that you get theartwork to be compliant with local requirements, and meet your manufacturing requirementswhilst 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 ourlinguistic skills to ensure all these competing factors are achieved. We take into account theblue box requirements, your printing limitations and ensure that we edit as professionally aswe translate. 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
  3. 3. Medical WritingPutting the Science into WritingDossier Preparation/Conversion - NtA to eCTDOur expert medical writers are able to make your dossier “Registration Ready” for whichevermarket 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 usingindustry standard eCTD software for electronic submissions, we offer the complete solution.Non Clinical & Clinical OverviewsWe understand the importance of getting Non/Clinical and Clinical Overviews correct. Ourwriters have the experience to write these in the most effective manner. We have invested inaccess to databases such as Embase, allowing us to provide you with a wide and deep range ofarticles to support this activity. Furthermore, we have a dedicated network of experts for anynational literature searching. Our medical writers are experienced in most therapeuticcategories, allowing us to cover nearly any kind of clinical and non clinical requirement.CTA & IMPDTo avoid delays in gaining regulatory approval, it is imperative to be very familiar with therequirements of a clinical trial application (CTA). This includes such requirements as those forpharmaceutical quality, as described in the investigational medicinal product dossier (IMPD).Our team ensures that by analysis of the submission package, we ensure being in compliancewith 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 PaediatricInvestigation Plans. Moreover, we can assist in the justification for a PIP Waiver, and havestrong practical experience in a range of different scenarios.Bioequivalence Studies/WaiversBE Study protocol design is very important for your future registration and approval, and it isnecessary for you to pick the right expert to compile it. We work alongside trustedlaboratories that conduct BE Studies and we provide the reporting capability – a completesolution. Be assured that we can help you with protocol design for any market, and our highlyexperienced scientific writing team will deliver the best results. 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
  4. 4. PharmacovigilanceYou’re Safe in Our HandsFull PV SystemWe have our own internal PV system to allow you the ability to use it either independently tosupport your activities or as part of the Arriello MAH service. Our PV system has been builtfrom the bottom up, working with distinguished external experts in the industry. With a highlyregarded QPPV and Deputy QP team, we will give you the peace of mind that your safety is inour hands.XEVMPD SupportWe provide a complete XEVMPD service by offering data collection, data entry and qualitycontrol by a highly reputed group of pharmacists and doctors. Moreover, if required we willwork remotely in your own XEVMPD system. Our QP and Deputy QP team have gained thenecessary qualifications to use the EMA EVWEB Trader tool and have the appliedunderstanding of the most important commercial packages that are on the market.EU QP and Deputy QP - In-HouseWe have invested in having experienced QP and Deputy QP’s, in-house. Moreover, we haveinvested in key people with many years international experience. We continually invest intheir education to remain at the forefront of understanding guidelines. Our PV team worksclosely with our in-house regulatory affairs team to ensure complete compliance andunderstanding.SOP/QMS PreparationWe have built our own PV system with detailed SOPs and an auditable QMS system. Ourexperience 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 orreview your SOPs and QMS to ensure that you have the utmost confidence in your ownsystem.Maintenance Documents - PSURs, RMPs, REMSWe have extensive experience in preparing high quality maintenance documentation such asDSURs, PSURs, RMPs, and REMS in order to ensure you are compliant. We have access to awide variety of databases and vast practical experience, enabling us to provide the mostaccurate literature searching to support such activities. 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
  5. 5. XEVMPD SupportManaging your Medicinal InformationOur ApproachHeaded by our EUQP and Deputy EUQP, we are in a strong position to offer you a bespokeXEVMPD service. We have been closely following the developments of XEVMPD and have putin place a management team with XEVMPD experience.We are software independent. If you have already purchased software to handle XEVMPDsubmissions, then we can work remotely in your system, as we would if we were usingEVWEB. 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 timeand to budget. We divide this submission into two different tasks: 1) XEVMPD Administration 2) Processing of Authorised ProductsProcessOur quality system applies its standards to this new area. Data Entry & Quality Control are thetwo key elements of our XEVMPD management process. The quality of personnel handlingthis process is key. Our QC Team, led by Doctors and Pharmacists, carefully selects the DataEntry 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 EMAWeb 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! 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
  6. 6. Medical DevicesAssuring Market Entry and Global ComplianceEuropean Authorized RepresentativeWe can be your European Community Representative. It means that we will be responsible tothe EU competent authorities to ensure that you, the manufacturer, fulfil all duties andresponsibilities as stipulated by the directives. We will take care of all necessary reporting,registration and communication with European authorities and bodies.Audit, SOP/QMS PreparationWe can prepare the complete quality management system (QMS) in compliance with ISO13485 / 21 CFR / Canadian Medical Devices Regulations including customized StandardOperating Procedures (SOPs) for Clean Rooms manufacture, sterilization and Medical DeviceVigilance system and Incidents / Near Incidents / reporting procedures, allowing you fasteraccess to market.Document Preparation for CE-Mark, 510 (k) ClearanceA Technical File / Design Dossier is required for all products falling under one of the threemedical device directives, including low risk Class I, custom made devices and procedurepacks. We will help you to comply with the necessary legislation and assist in ensuring thatyour QMS / Technical File / Design Dossier is ready for review by a Notified Body (as and whennecessary) or the local Competent Authority in Europe / USA / Canada / other countries.RMP Guidance Compliant with ISO 14971We can ensure that your medical devices are in full compliance with ISO 14971 (Medicaldevices — 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. Wewill 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. Arriellowill ensure your QMS is certified by a CMDCAS recognized registrar.We can provide registration in almost every country of the world as required by localcompetent authorities. 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
  7. 7. Medical DevicesAssuring Market Entry and Global ComplianceMedical Device VigilanceWe can provide consultancy services in PMS (Post-Marketing Surveillance) and vigilance fordevices, be they device-alone or drug device combination products, as part of our MedicalDevice / Pharmacovigilance service. We also prepare Periodic Vigilance Reports: Complete andSubmit Periodic Summary / Trend Reports to any National Competent Authority.Monitoring of StandardsWe can research the standards applicable to your products and monitor these standards toensure that you comply with them. These include the most important standards such as thosebeing issued by the United States - American Society for Testing and Materials InternationalOrganization for Standardization; European Union - European Committee for Standardisation.Local SupportOur in-house of experts together with our network of high trusted partners allow us to offer awide coverage and reach countries other companies can’t with out assistance, you can handleissues at local level in countries in which you don’t have physical presence!LabelingWe can create complete labeling support for your medical devices and ensure you will be fullycompliant with all required regulations including EU, USA and Canada. Moreover we canreview your current labeling to ensure continuous compliance.Research and DevelopmentWe can assist you with your new product development, from initial set up to final approvalfrom the relevant authority. We help you find and understand the requirements and to createall the supporting documentation for product development, including DHF and DMR.RegistrationsA Technical File / Design Dossier is required for all products falling under one of the threeMedical Device Directives, including low risk Class I, custom made devices and procedurepacks. We provide registration support for Medical Device companies.We will assist you to comply with the necessary legislation, ensuring that your documentationis ready for review by a Notified Body (as and when necessary) or the local CompetentAuthority in Europe / USA / Canada or other countries. 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
  8. 8. Business DevelopmentMaximizing your Sales & Market OpportunitiesIn/Out Licensing SupportThrough our extensive business network we select the companies with the strongest salesforce in each country, and secure the maximum supply for your product. Moreover, we willdesign the best regulatory, business and pricing strategy for your dossier. We will help you toget your product to new markets in the shortest amount of time.Co-DevelopmentWe don’t just work with pharmaceutical companies; our network consists of manufacturersand key R&D facilities. If you are looking to develop a product and looking for a legitimatepartner to do it with, then Arriello can provide all the necessary support.Market ResearchWe provide a comprehensive and tailored market research service to clients. We can helpwith identifying trends in markets, entry strategies and locate possible partners, just to namea few. We operate in many markets so our research is as practical as it is academic.Exports & Tender SupportWe 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 supplyby selling via: • Marketing and distribution pharmaceutical companies • Wholesalers and pharmacy chains in Europe, the Middle East and CIS • Public Sector Tenders 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
  9. 9. 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’sArriello 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

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