This document discusses trends in the global regulatory affairs landscape and outsourcing approaches. It notes that while offshoring was seen as a way to cut costs, clients now recognize losses in quality and sponsor control. Nearshoring locations like Belfast and Costa Rica are seen as more cost-effective while maintaining quality. Additionally, clients want outsourcing to add value beyond cost-cutting by providing new skills and expertise. The document is authored by Dr. Ivan Fisher from G&L Scientific, a regulatory consulting firm that provides global services to life sciences clients.

1. SCIENTIFIC
Clinical Research & Regulatory Affairs
CLIENT-FOCUSED. INDUSTRY EXPERTS.
GLOBAL TRENDS IN THE
REGULATORY AFFAIRS LANDSCAPE
INTRODUCTION
The ever-changing landscape of globalregulatoryaffairs provideschallenge, risk and opportunity in equal measure, for
healthcare stakeholders. This white paper highlights some of the most significant and recent regulatory trends that G&L
Scientific is successfully addressing with its clients.
A FRESH APPROACH TO GLOBAL
OUTSOURCING IS REQUIRED
The use of external suppliers to augment or outsource
key regulatory and clinical functions is nowadays largely
seen as a key element of normal practice within the life
sciences industry.
Driven by a growing need to reduce costs, cut overheads,
increase productivity, scalability and flexibility, and access
new skills, outsourcing is now commonly viewed as a
long-term strategic partnership. This contrasts with the
historical view of such engagements as either providing
"temporary labor" to service transient peaks in demand, or
simply being a cost-cutting exercise.
The case for outsourcing within this competitive industry
sector is certainly compelling. Ever-increasing regulatory
and compliance pressures, combined with a need to focus
upon core, revenue-generating activities, set the scene for
a progressive, strategic approach to resourcing.
However, our clients are increasingly reporting that in the
rush to outsource aspects of regulatory to lower-cost,
off-shore locations over recent years, something has been
lost. Long-perceived as a cost-effective solution to
managing regulatory budgets, the use of off-shoring
locations is now coming under increasing scrutiny and the
"real-world" cost-effectiveness being called into question.
Our clients are increasingly recognizing that loss of
sponsor control, high staff-turnover rates, and time-zone,
cultural and linguistic differences are often associated with
a decrease in quality of output for all but the most
transactional activities.
Our clients are recognising that the use of a near-shore
location such as Belfast or Costa Rica for outsourcing
overcomes this dilemma, and delivers a solution that is
simultaneously cost-effective, stable and scalable. Sponsor
control is maximized, time-zones are synchronized and
quality of output assured.
Furthermore, beyond the classical "more with less"
philosophy commonly associated with outsourcing, our
clients are increasingly looking to add value. A staff
augmentation model, used either in conjunction with a
near-shored outsourcing model or on its own, provides
the opportunity to inject new skills and local expertise
into an organization.
000 www.gandlscientific.com
UK Head office: Marlow, Buckinghamshire;US Head office: Warren NJ;
T: +1 800 975 6415 E: hello.nj@gandlscientific.com T: +441628 400686 E:hello.marlow@gandlscientific.com
EU office: Drogheda, Ireland;
T: + 353 87 409 8458 E:hello.ireland@gandlscientific.com

4. ABOUT G&L SCIENTIFIC
G&L Scientific was founded by industry veterans, Peter Griffin and Stephen Loughrey, following the sale of their former
company, Pharmalink Consulting, in 2014. Since then, G&L has experienced rapid growth, expanding into every major
geography to become one of the most admired scientific consulting organizations.
Founded on the principle of great people backed by great customer service, G&L Scientific provides consulting, staffing and
support across Clinical Research and Regulatory Affairs.
With a fast-growing team of over 100 experts based in our offices across the US, Europe, Latin America and Asia, as well as a
pool of 2,500 consultants across our ORBIS network in over 100 countries, G&L Scientific has the right professionals, at the
right level, in the right location to fulfil your Clinical and Regulatory requirements on a global basis.
000
US Head office: Warren NJ;
T: +1 800 975 6415 E: hello.nj@gandlscientific.com
SCIENTIFIC
Clinical Research & Regulatory Affairs
CLIENT-FOCUSED. INDUSTRY EXPERTS.
ABOUT THE AUTHOR:
Dr Ivan Fisher- Vice President, Regulatory Affairs­
G&L Scientific.
Vice President, Regulatory Affairs who has made a direct
and lasting contribution to the sustained global regulatory
conformance of many multinational clients.
Over 15 years of experience in Regulatory consulting, with
experience spanning the pharmaceutical, consumer
healthcare and generics industries. Recipient ofTOPRA
Distinguished Service Award in 2014.
If you have any questions, comments or wish to discuss
any of the topics covered within this white paper, please do
not hesitate to contact Ivan at:
ifisher@gandlscientific.com
www.gandlscientific.com
UK Head office: Marlow, Buckinghamshire;
T: +441628 400686 E: hello.marlow@gandlscientific.com
EU office: Drogheda, Ireland;
T: + 353 87 409 8458 E:hello.ireland@gandlscientific.com