G&L Scientific has a global team of experts, with in-country knowledge of regional and national regulations, across multiple Therapeutic Areas—Oncology, Pharmaceutical, Biotechnology, Consumer Healthcare, Medical Devices, Generics, Veterinary.

1. CLIENT-FOCUSED. INDUSTRY EXPERTS.
G&L SCIENTIFIC CAPABILITIES
Millburn, NJ | La Jolla, CA | Cambridge, MA | Marlow, UK | Belfast, UK | Dublin, Ireland

2. Worldwide: Consulting | Staff Augmentation | Support www.gandlscientific.com
THE RESULT
A stress-free
experience that
is right first time
ADDED VALUE
CONFIDENCE:
All our consultants are vetted and
hand-picked by our highly-experienced,
in-house clinical experts, with your specific
project in mind. While we ensure your
consultant has the appropriate technical
experience we also pay particular attention
to their personality and core values, to
guarantee a good cultural fit with your
existing team and company.
CONTINUITY:
Our consultants fully understand the
importance of continuity to see a project
through to completion; we have an
excellent reputation within the industry
for the quality of our service.
MAXIMIZING YOUR TIME:
Throughout the project, our consultants
are continually overseen to ensure
we are exceeding your expectations.
A Project Lead will also maintain contact
with you at an agreed frequency, to
make sure you are completely happy
with our service and address any issues
that may arise.
ACCELERATED ONBOARDING:
Our staff are experienced in the use
of multiple systems. This speeds
up the onboarding process so
our consultants can hit the
ground running.
We know the challenges you face; we’ve sat where you’re sitting.

3. Worldwide: Consulting | Staff Augmentation | Support www.gandlscientific.com
ACROSS MULTIPLE AREAS
• Pharmaceutical
• Biotechnology
• Consumer Healthcare
• Medical Devices
• Generics
• Veterinary

4. Worldwide: Consulting | Staff Augmentation | Support www.gandlscientific.com
AREAS WE WORK IN
GLOBAL
REGULATORY
INTELLIGENCE
REGULATORY
STRATEGY
DOSSIER
PREPARATION
& SUBMISSION
MEDICAL
WRITING
LICENSE
MAINTENANCE
COMPLIANCE
REVIEWS &
REMEDIATION
OUTSOURCING

5. Worldwide: Consulting | Staff Augmentation | Support www.gandlscientific.com
G&L REGULATORY
INTELLIGENCE
Access to current, validated and first-hand
Regulatory Intelligence has never been so
important, in order to successfully navigate
approval pathways in new markets.
• Current, validated and relevant Regulatory
Intelligence to register products in new markets
• Local knowledge from experts
working in the field
• Our Global Scientific Partner Network saves
you time, money and stress:
- Provision of critical, tailored
Regulatory Intelligence
- Right-first-time submissions
- Faster approvals
AREAS WE WORK IN
GLOBAL
REGULATORY
INTELLIGENCE

6. Worldwide: Consulting | Staff Augmentation | Support www.gandlscientific.com
G&L REGULATORY
STRATEGY
The effective application of scientific,
product-specific and local knowledge is at the foundation
of a successfully-executed Regulatory Strategy.
• Regulatory Strategy specific to product type
and approval market
• Our experts will work closely with you to
understand and achieve your goals:
- Solid, well-planned strategic roadmap for product
registration, minimizing delays in approval
- Deep expertise in all phases of drug lifecycle,
including pre-clinical, clinical, CMC and post-approval
- In-country consultants in over 100 markets,
best placed to advise on regional/national
regulations and local hurdles
• Detailed post-approval advice on
requirements to maintain
your license
AREAS WE WORK IN
REGULATORY
STRATEGY

7. Worldwide: Consulting | Staff Augmentation | Support www.gandlscientific.com
G&L DOSSIER
PREPARATION & SUBMISSION
Carefully-considered, well-written and comprehensive
submission packages are a central factor in achieving
regulatory approvals in a timely manner
• Familiarity with the regulations and timelines
of different Health Agencies around the world,
for successful submission and speedy approval
• All product types covered, including
Biotechnology, Pharmaceuticals, Medical Devices,
Consumer Healthcare and Generics
• Assurance that your dossier contains
the correct technical data for approval
(Administrative, Quality, Non-Clinical and Clinical)
• Submission of application
and liaison with the Agency
AREAS WE WORK IN
DOSSIER
PREPARATION
& SUBMISSION

8. Worldwide: Consulting | Staff Augmentation | Support www.gandlscientific.com
G&L MEDICAL
WRITING
• Our native English writers and local
language writers are experienced across a wide
range of medical and scientific subjects,
multiple therapy areas and product types
• Clinical Documents
- Investigator Brochures - Protocols/ICs
- Clinical Study Reports - Clinical Expert Reports
• All Modules of the Application Dossier
- Administrative - Quality
- Non-Clinical - Clinical
• Journals
• Manuscripts
• Conferences
• Abstracts
AREAS WE WORK IN
MEDICAL
WRITING

9. Worldwide: Consulting | Staff Augmentation | Support www.gandlscientific.com
G&L LICENSE
MAINTENANCE
The License Holder is legally responsible
for making sure their License is properly
maintained, and the product is strictly
manufactured to approved terms
• G&L has extensive experience in conducting
License Maintenance activities across the
world, with many different Health Agencies
and all product types:
- Putting License Maintenance processes in place
before Marketing Authorization is granted to
minimize risk of future compliance issues
- Post-approval activities, including
preparation and submission of
Variations, Renewals,
Line Extensions and
Safety Updates
AREAS WE WORK IN
LICENSE
MAINTENANCE

10. Worldwide: Consulting | Staff Augmentation | Support www.gandlscientific.com
G&L COMPLIANCE
REVIEWS & REMEDIATION
The pressure on businesses to ensure
CMC Regulatory Compliance has never
been higher, in terms of potential penalties,
litigation and impact on brand perception.
• G&L supports compliance efforts by:
- Reviewing your License against
manufacturing processes and practices
- Conducting Gap Analyses to highlight
non-compliance issues
- Putting a Remediation Plan in place
- Preparing Variations and submitting
to relevant Agency
AREAS WE WORK IN
COMPLIANCE
REVIEWS &
REMEDIATION

11. Worldwide: Consulting | Staff Augmentation | Support www.gandlscientific.com
CLINICAL
CONSULTING
G&L STRATEGIC
OUTSOURCING
Over the past 10 years, Outsourcing
has become a hot topic within Regulatory Affairs:
everyone is doing it. But is it right for your
business, and what should you outsource?
• G&L will give you the very best advice by:
- listening to what you say, to gain a deep
understanding of your business
- strategizing on how to achieve your goals
through working with external agencies
- working in genuine partnership with
you for as long as you need us
AREAS WE WORK IN
OUTSOURCING

12. Worldwide: Consulting | Staff Augmentation | Support www.gandlscientific.com
STAFF RECRUITMENT AND RETENTION
TYPICAL ISSUES FACED
BY CLIENTS:
•Lack ofexperiencedtalentinthemarketplace
• Competitive industry sector
• Geographical restrictions
wide pool of talent with differing
levels of experience.
For scientific positions, a relevant
qualification in the candidate’s scientific
field and some exposure to working in
Industry are minimum requirements.
Initial telephone screening (using
competency-based questioning, devised
to match the job and person specification),
is followed by a face-to-face interview with a
recruitment specialist and one of our
Regulatory Operations management team.
CANDIDATE CARE:
Monthly one-to-one meetings are held with
every employee to discuss performance
issues, Client relationships and the project
itself. We also talk to the Client at least once
a quarter to ensure they are satisfied with
performance. Feedback is provided to
consultants immediately.
CANDIDATE SOURCING:
Our extensive workforce of Regulatory
Professionals is maintained and grown
through creative recruitment techniques
including networking, referral schemes,
incentives, advertising and job boards,
recruitment fairs, exhibitions
and conferences.
We look at the job specification and
our current resources, and match an
appropriate skill set from our available
pool of specialists, including freelancers.
We hold regular meetings with our
Clients to pre-empt any resource
requirements they might have. We
also allocate an account manager
to each Client to ensure ease and
consistency of contact.
SELECTION PROCESS:
We meet Client expectations by having a
We care for our
consultants with
the same passion
as we care for
our clients
Recruitment process / assurance of supply

13. Worldwide: Consulting | Staff Augmentation | Support www.gandlscientific.com
INTERNATIONAL PRESENCE
With local expertise
ready to help in more
than 100 countries,
we offer a truly
global service

14. Worldwide: Consulting | Staff Augmentation | Support www.gandlscientific.com
SYSTEMS EXPERIENCE
®
BENEFIT FROM
OUR EXPERIENCE.
Our consultants will hit
the ground running