Some of our Patient Safety & Patient Safety & Compliance

Compliance experts
NDAs insight into pre- and post-marketing safety, and
understanding of the needs of a quality management system,
help you maintain and develop an in-depth understanding of
your products safety profile.
In turn this will ensure proactive management of your product
throughout its life on the market in a stable fashion, providing
peace of mind and rapid response to any emerging concerns.
Working with NDAs Patient Safety & Compliance
experts you will:
Reduce the risk of marketing authorisation application
Patient Safety &
Compliance
rejections and product withdrawals, saving time and money
Increase efficiency by doing things right first time
Achieve faster and less costly time to market through
efficient processes, tools and decision making

Shelley Gandhi Helen Powell

Strategic Advisor, PV & Drug Safety Principal Consultant

Dr Julia Dunne Dr Bill Richardson

Medical Advisor Medical Advisor

NDA Germany NDA Sweden

T +49 (0)89 3585 4000 T +46 (0)8 590 778 00
Dr Brian Edwards Dr Panos Tsintis
Principal Consultant Medical Advisor
E munich@ndareg.com E stockholm@ndareg.com

NDA Switzerland NDA UK

T +41 (0)78 951 9929 T +44 (0)1372 860 610
Dr Bridget King Kath Denton E zurich@ndareg.com E london@ndareg.com
Senior Consultant Senior Consultant

NDA USA
T +1 609 583 1990
E usa@ndareg.com
Helen Measures Barbara Jones
Senior Consultant Senior Consultant

www.ndareg.com www.ndareg.com www.ndareg.com

Patient Safety &
Compliance Services
Drug development is a long and costly process.
Ensuring that the right things are done the right way first
time is critical to reach patients in need as quickly as
possible, as well as ensuring that the right measures
are taken to ensure patient safety throughout the
development process.
NDA offers advice throughout the lifecycle of your product,
from development and approval, to post development
activities. This includes advice and hands-on support with
your risk management, pharmacovigilance and patient
safety strategy and organisational implementation. Our
safety team comprising over 20 specialist auditors and
quality management experts further supports the continual
development of your practices and ensuring that these
practices become embedded in your organisation.
This way we are ideally placed to help you get the best drugs
on the market and keep them there.
Develo
Deve
re
me
nt Co
lop ormation
Why choose NDA? How can NDA support you?
At NDA we have in-depth understanding of global We provide practical and up-to-date advice about all
Pharmacovigilance and the tools required for system your requirements for safety to help you establish and
oversight, to direct and control a companys quality across strengthen pharmacovigilance and risk management and
the lifecycle. Our skilled team will help you implement your mitigation strategies within a quality management system
systems as effectively as possible. to promote effectiveness and compliance.
We understand exactly what international legislation NDA can assist with consulting, training or operational support
demands, the meaning of quality and how you should and project management. Examples of safety
efficiently comply to meet regulatory expectations both for support provided:
routine maintenance and when faced with safety referrals.
EU/EEA Qualified person for pharmacovigilance services
We have worked with a great variety of companies, in the US, including back up arrangements
Europe, Japan, Korea and other territories concerning different
Advising companies on the development of your global PV
medicinal products across all major therapeutic areas.
system through your PSMF
NDAs integrated Safety Services gives comprehensive support
Developing and Advising on Risk Management /
and an expert view about the safety of your product including
Minimisation strategies (RMP/REMS) and contingencies
Risk Management strategies and requirements of your
including input at regulatory milestones and into post
quality system through the entire lifecycle. The team provides
authorisation commitments
assurance as to the compliance status through bespoke risk
based auditing approaches and supporting the QA function to Other medical writing services include DSURs, PBRERS, SOPs
pm strengthen your system of compliance.
en Building global signal management systems and conducting
t Ph
lop as safety signal generation and analyses as well as conducting
Man ment
ag Different competencies, processes, systems and tools are
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ve
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g required throughout a products lifecycle to place treatments ad-hoc safety assessments following requests from
Sa
Pha on the market and keep them there. We have the skills and regulators.
rm
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THE HEART resources on hand to address any need. Audit strategy and support including developing
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risk-based audit strategies, audit plans and the conduct

Post Authoris

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A Manag

Qualified
of Pharmacovigilance and GCP Audits, Inspection readiness,
ce Audits
ation

Persons for
PV Service support during inspections, and support with development
(QPPV)
CAP
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of responses/CAPAs.
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Management of regulatory interactions concerning:

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- Pre-submission meetings
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Sy - Management of questions during the approval procedure
R is k M
anage
Pe
m e nt Managing risk ensures product survival
- Safety referrals at PRAC and CHMP
ri-
Plan Au
tho
risa
tion
in a competitive market. - Negotiations about Safety studies and commitments
- FDA Advisory Committees

Support through the lifecycle

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