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Follow on Google News | Pharmacovigilance services for Global market announced by Helix Research Center Ltd,United KingdomPortugal based Yabulu and United Kingdom based Helix Research Center Ltd,have entered strategic Alliance to offer Pharmacovigilance services worrldwide.
2010 © Yäbulu - Page 1 of 4 - BIZ.01.DRI.02 Company Information 2.0 Expert Advisory. Value Driven. 1.. IIntroductiion Pharmacovigilance is a dynamic, changing area. Keeping up to date and dealing with the myriad of requests pouring from the Regulatory Authorities is both human and financially demanding. Our objective is to help your company to level with the legal requirements, as well as with the regulatory inspectors’ expectations. Through our broad and evolving services offering, you can rely on us to take care of any pharmacovigilance task pertaining to the marketing authorisation holder. Whether you want to delegate all of your pharmacovigilance tasks or on-request aid and consultancy, we will provide added value services to your company. If you are not sure which services your company might need, just get in touch with us and we will be happy to find the best solution for you. 2.. About Yäbullu Yäbulu is an advisory company specialized in Pharmacovigilance. Born from the desire to work better and excel in pharmacovigilance advisory, our name Yäbulu mirrors our business philosophy meaning "very good" in Australian Aboriginal Yanyuwa language. From Lisbon , Portugal , we work with clients worldwide. We aim to exceed expectations. We focus on understanding your objectives, analyse the issue, propose a solution and take full ownership of the project and delivery. Our team members have specialised background, training and experience to take your company where you need to go. Our young and dynamic team is prepared and willing to take up new challenges and has rich experience to surpass them. Yäbulu invests in people through our continuous people development programme which includes memberships of associations like the DIA, BARQA and APREFAR. We are looking forward to working with you! 3.. Core Vallues & Viisiion Five shared values that form the basis for Yäbulu’s operations: Company Information 2010 © Yäbulu - Page 2 of 4 - BIZ.01.DRI.02 Company Information 2.0 Expert Advisory. Value Driven. Excellence – As a standard of our work. We aim to exceed expectations. It is our best guarantee that the services we provide project the image of our company the way we perceive it. Integrity – In the way we do business. Refusal of unfair business practices and respect for our clients, partners and team members. We may have to refuse business should we feel it attempts against good faith or violates our ethical values. We endorse transparent communication with all our stakeholders. Creating partners – We believe that sustained growth can only be achieved by turning our clients and competition into business partners, who will reference our company, our team and our work based on their positive experiences. Building relations on doing the right thing. Client value creation – In every business we do, we focus on the added value that our services bring to the client. We continuously search for ways to improve. Investment in People –People are our greatest asset. Investment in people creates a strong internal structure that allows a company to work harder and better while increasing its human capital and expertise. Vision To provide solutions with a superior execution and delivery in a transparent, professional way, granting our clients high value, flexibility and optimisation of their resources (human and financial). 4.. Serviices & Sollutiions We are qualified and willing to perform any or all pharmacovigilance activities on behalf of your company. Our services include: Pharmacovigilance audits. Preparation for regulatory inspections. European and Portuguese QP for PV position. SOP writing and reviewing. Pharmacovigilance training. PSUR writing and reviewing. Literature search & Review. Registration with Eudravigilance for electronic reporting using the EVWEB. Individual Case Safety Report Management. Company Information 2010 © Yäbulu - Page 3 of 4 - BIZ.01.DRI.02 Company Information 2.0 Expert Advisory. Value Driven. We will be happy to talk to you and understand how our services can be the solution to your company. We have the pharmacovigilance know-how and have fun doing it! Pharmacoviigiillance audiitts Audits are valuable tools to diagnose problems and indispensable in a quality assurance system. Yäbulu performs independent, high standard pharmacovigilance audits to your company, affiliate or licensing partner. Preparattiion for regullattory iinspecttiions Regulatory authorities are becoming increasingly active in their inspection activities. If you have been booked for a pharmacovigilance inspection or just want to be sure that your company is ready to undergo one, Yäbulu can prepare you. European and Porttuguese QP for PV posiittiion It is an European requirement that a MAH has a QP for PV residing in the EEA. Additionally, Portuguese authority requires that MAHs with a MA in Portugal must have a local QP for PV residing in Portugal. If you have no need to assemble an office in Portugal or Europe, Yäbulu has qualified staff to fulfil the role of European or local QP for PV. Sttandard Operattiing Procedures wriittiing and reviiewiing SOPs are a fundamental part of the pharmacovigilance systems. We are willing and able to write or review your pharmacovigilance SOPs, either locally, regionally or globally. Pharmacoviigiillance ttraiiniing Yäbulu is prepared to train you and your employees in any aspect pertaining to pharmacovigilance. Please see additional information specific on training. Periiodiic Safetty Updatte Reportt wriittiing and reviiewiing PSURs writing is time consuming. At Yäbulu we are experts at writing high quality PSURs. We can also simply review the PSURs you have written to ensure quality and consistency. Liitteratture search At Yäbulu we have wide experience at performing local and worldwide literature searches for information eligible for PSURs inclusion or just ICSRs. ICSR Managementt We cover all stages of ICSR management: triage, data entry, quality control, medical review, submission and follow-up. We can take care of the whole process for you, or simply one or more of the mentioned steps. Company Information 2010 © Yäbulu - Page 4 of 4 - BIZ.01.DRI.02 Company Information 2.0 Expert Advisory. Value Driven. Regiisttrattiion wiitth Eudraviigiillance for ellecttroniic reporttiing usiing tthe EVWEB Registering with the Eudravigilance allows your company to report electronically using the EVWeb tool. The EVWeb is free of charge and represents an economic way of fulfilling the requirement of electronic reporting for companies with a small number of ICSRs. 5.. Contacts E-mail: mail@yabulu.com Telephone: +351.210.134.486 Fax: +351.210.103.876 Webpage: www.yabulu.com # # # Helix Research Center Ltd is a London based multinational company offering Contract Research,Training,Healthcare,Consulting,Medical writing,Auditing,Pharmacovigilance,Publication,Translation,C End
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