Pharmacovigilance services for Global market announced by Helix Research Center Ltd,United Kingdom

July 13, 2010 - PRLog -- Company Information
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,Clinical Data Management,Regulatory Affiars,Quality Assurance,staffing services et in North America,South America,Asia,Africa,Europe,and Oceania.