G&L is a market-leading, multi-national,scientific consultancy at the forefront ofRegulatory Affairs and Quality Assurance.

With over 300 consultants working across all levels – from 2 to 25+ years’ practicalexperience – making G&L one of the top 10pureplay Regulatory Affairs and QualityAssurance consultancy firms in the world.

Providing strategic consulting, outsourcingand functional support across our globalhubs, we pride ourselves on having the scalability and coverage of a largemultinational, while providing theresponsiveness, agility and cost-effectiveness of a boutiqueconsultancy.

We understand the importance of fosteringopen, transparent and collaborativepartnerships with our clients in order toensure the highest levels of quality, whilstsimultaneously driving operational and costefficiencies.

We add value through experience-based

process improvement, providing ring-fenced

project management, implementing

train-the-trainer models, identifying

contingency pools of expertise and

providing executive governance.

We believe in aligning our culture, values

and goals to those of our clients, creating

an environment of mutual success and

shared risk and reward.

Above all, we are passionate about

providing an unfailingly quality- and

client-centric service. We achieve this by

recruiting, developing and retaining only the

very best talent.

ate a

al

ac

re

About G&L Scientific

ss

orking acrars’ practic

f th

ss

wo rar ic

of th

RA and QAcontingent

technical resource.All levels of

experience. Goodcultural fit. Specific

expertise

Specific, routineactivities. Essential

for business.Allows client to

focus on key valuedrivers

Full/part portfolio ordepartment. Allowsclient to focus onkey value drivers

Functional ServiceProvision

StrategicConsulting

Contract StaffingServices

Planned ProcessOutsourcing

High-level strategy.Specific

project/goal

Engagement Models

High-level strategy.Specific

project/goal

Specific, routineactivities. Essential

for business.Allows client to

focus on key valuedrivers

RA and QAcontingent

technical resource.All levels of

experience. Goodcultural fit. Specific

expertise

Global Coverage

The team at G&L has proven success in working directly with local

authorities in established and emerging markets around the

world on behalf of our clients.

This exposure to different regulations

and agency nuances and cultures

has proven to be of great

benefit to all of our

clients.

G&L’s management team has decades of experience in Regulatory Affairs and Quality Assurance, successfully tackling some of the most technically challenging projects to deliverexceptional value to clients fromcommercial and scientific standpoints.

We have proven expertise in providing solutions for all ranges of

scientific assignments, regardless of size, location or timescale.

Global Expertise

The demand for expert, scientific consultancy has never been greater. Clients of all sizesare driven by a growing need to reduce costs, cut overheads, increase productivity,scalability and flexibility, as well as access new skills. G&L places a lot of importance, not only on the technical capabilities of their people, but also on Customer Care. As a result, repeat business figures are in excess of 95%.

Client Challenges

9955%

Regulatory Affairs

"T"T" hThT e G&G&G L&L& team workrkr s

so clolol selylyl wititi h mymym team that

I genuinini elylyl consididi eded r them as

an exexe tensioioi n to mymym team.... SeSeS amlelel ss!s!s "!"!

HeHeH ad of ReReR gege ulalal toryryr Afffff afaf iriri s,s,s lelel adidid nini g

EuEuE ropopo ean PhPhP arma CoCoC mpmpm anynyn

"G&L’s global

strategic guidance gives

clients a competitive edge."

VP Regulatory Affairs,

United States

FILING STRATEGY

- US, EU, International- Regulatory Intelligence

- Dossier Build (CTD Modules 1–5)

- Artwork/Labelling

MAINTENANCE- Variations- Renewals

- Annual reports- Line extensions

- New market roll-out- Artwork/labelling

changes- GMP audits

CLINICAL- Clinical

trial advice- CTAs/INDs- GCP audits

and inspections

PUBLISHING & SUBMISSION

- eCTD, NeeS and Paper- Agency Portal

Submission - Local Support

APPROVAL- Response to

Questions- Labelling Negotiations

- National Phases

End-to-end Services...

DEVELOPMENT- Regulatory strategy

and advice- Literature reviews

and claims assessment

- Medical writing

End-to-end Services in...

Pharmaceutical

BiotechnologyConsumer Healthcare

Medical DevicesGenerics

Animal Health

G&L recognizes the huge commercial value of accelerated drug

development and market approval.

The company is a recognized expert in creating innovative regulatory

roadmaps from early development right through to successful approval and

beyond in any market around the world.

G&L exhibits a relentless pursuit of excellence and

quality in every aspect of its work and, as a result,

has earned an exceptional reputation in the industry

for getting things ‘right first time, every time.’

Regulatory Strategy services include:

• Local Intelligence globally

• Risk management planning

• Agency meetings

• Scientific Advice and Protocol Assistance

• Response to Agency questions

• Advisory Committee meetings & preparation

• Lifecycle management

Regulatory Strategy

Clinical Trial Filing (CTA and IND)

GxP support from Clinical Trials through

Manufacture to Market

Filing Designation – NDA, ANDA, BLA, MAA,

Orphan

Biowaiver, PIPs

Global Regulatory Intelligence

Preparation and attendance at

Expert Advice (Non Clinical, Clinical and Quality)

Non-Clinical and Clinical Overviews and Summaries

Medical Writers

Dossier Authoring

pre-submission meetings (IND; Scientific

Advice; NDA, BLA, EU filing agency

advice)

Getting things started ...... Pre-approval support

What Filing Strategy is best for you

How to build the optimum

submission package

Publishing and portal submission

Expertise for all stages

Artwork and Labelling

Guide you through the

How to deal with Regulatory

Agencies (scientific advice; agency

meetings; response to questions)

Market Approval

submission process

Roadmap to approval ...here's how we can help

Changes to your product licence(variations, amendments,supplements, line extensions,

Annual ReportsRenewalsSubmission Management andPublishingGrowth in new markets

Intelligenceauthoring and filinglocal support

QualityPharma Quality ComplaintsAnnual Product Reviews

CCDS updates)

Post-approval Commitments... ... our ongoing support

CMC

No matter what kind of license you have got – there

will undoubtedly be some CMC aspect to it.

CMC

Over of

been doing for years

It's fair to say

pretty expert at what

50%

CMC-related

this

we are

is

we do

We've

ourwork

Strategic drug development, support and guidance Authoring of CMC CTD documents (Modules 2.3 (QOS) and 3)Authoring of CMC modules for IMPD, INDsASMF/DMFs and CEPsAgency meetings and negotiationsVariations, supplements, amendments, line extensionsRenewals and annual reportsCMC compliance reviewsDue diligence reviewsManufacturing site transfersChange of ownership

Combining the flexibility of a boutique specialist with the global reachof a large multinational, G&L is expertly placed to provide a full rangeof global CMC services.

CMC Organization

Available to work on site or remotely from our global hubs

CMC Strategists Senior CMC Managers CMC Associates

60 80 40

Pharmaceutical | Biological | Medical Devices | Consumer Healthcare | Generics | Biosimilars

Medical Devices

Certification of Medical Devices and In Vitro Medical Devices in EU/USHelp with Conformity AssessmentPreparation of Declaration of ConformityCE MarkingMDD to MDR TransitionFiling for 510k

G&L has a broad range of experience in Medical Device consultancy in theUSA, Canada, EU and International Markets, and covering all risk classes.

The company provides a full range of consulting and contract services forthe development and registration of medical devices worldwide.

G&L also provides strategy and hands-on support for IVDR/MDR, helpingclients to navigate the new definition and classification systems.

QQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQuQQQQQQaQQQQQQlQQQQQQiQQQQQQtQQQQQQyQQQQQQAQQQQQQsQQQQQQQQQQsQQQQQQQQQQQQQQsQQQQQQQQQQQQQQuQQQQQQQQQQQQQQrQQQQQQQQQQQQQQaQQQQQQQQQQQQQQnQQQQQQQQQQQQQQcQQQQQQQQQQQQQQeQQQQQQQQ

QQQ

uQQ

QQ

uQ

QQQ

aQQ

uQ

aQ

uQQ

lQQ

aQ

lQ

aQQ

iQQ

lQ

iQ

lQQ

tQQ

iQ

tQ

iQQ

yQQ

tQ

yQ

tQQ

iQQ

sQQ

iQ

sQ

iQQ

nQQ

oQQ

nQ

oQ

nQQ

tQQ

oQ

tQ

oQQ

aQQ

nQQQQnQQQQaQ

nQ

aQQQQaQQQQQQcQQQQQQaQQQcQQQaQQQQQQtQQQQQQcQQQtQQQcQQQQ.QQ.QQ.QQiQQtQQiQtQiQQiQQsQQiQsQiQQaQQhQQaQQhQaQhQQbQQaQbQaQQiQQbQiQbQQtQQiQtQiQQAQQ

rQQ

AQ

rQ

AQQ

iQQ

rQ

iQ

rQQ

sQQ

iQ

sQ

iQQ

tQQ

sQ

tQ

sQQ

oQQ

tQ

oQ

tQQ

tQQ

yQ

tQ

yQQ

oQ

tQ

oQQ

lQQ

tQ

lQ

tQQ

eQQ

lQ

eQ

lQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQ

25+

G&L understands that every project is unique. As a result, the company offers a flexibleapproach to meet clients’ specific needs. Consultants work closely with companies to develop and maintain sustainable GxPcompliant programs and quality systems. The company provides Quality Assurance expertise from clinical to commercial, withresource in Europe, Canada, the US, and international markets. G&L’s senior consultants have in excess of 25 years’ experience in a range of industry sectors.

Quality Assurance Capabilities

GMPGMP

GMP

GMP

Site and/or System Gap Assessment

Assistance with and/or hosting of Regulatory Authority Inspections

Oversight of suppliers

For cause audits

Assessment, development and implementation of GMP Quality

system

On-site and/or remote Quality support

Remediation

Person in Plant

Support application, amendment and renewal of Drug Establishment

Licence

GMP training

QP services

Here's what we can do ...

GMP

GMP

G

G&L’s team will assist clients in the

design, planning and conduct of their

clinical trials.

Here's what we can do...

GCP• Sponsor/Study Site and/or System Gap

Assessment

• Hosting of, and/or assistance with,

Regulatory Authority Inspections

• Assistance/guidance for studies on

clinical hold, sites with compliance

issues

• Remediation work

• Audits of Trial Master Files;

Clinical/Investigator Sites; CROs

• For cause audits

• Assessment, development and

implementation of GCP Quality system

• On-site/remote Quality support

• Site and Project Management services

• GCP training

What else are we known for?

the standard:

M&ABespoke is a fully-integrated Regulatory and

Quality service designed specifically for small

and emerging Pharma and Biotech

companies. We shepherd your product

through development and to market.

Orbis, G&L's network of regulatory and quality

experts providing local, strategic and hands-on

expertise in over 100 countries.

the standard uses proprietary tools, templates,

methodologies and expertise to ensure that our

clients meet their ongoing CMC compliance

obligations.

Full support of M&A activity, spanning

pre-deal activities – due-diligence reviews –

to post-deal integration including change of

ownership, address changes, site transfers,

artwork and labelling changes.

InnovationG&L will develop and offer innovative operating and pricing

models that reflect the changing face of the industry whilst

retaining the client-centric and quality-driven philosophy

that clients demand.

Cost-effectivenessDelivered through a combination of quality and pricing. G&L will ensure that clients will never be charged for onboarding, project governance, candidatebackground checks and screening, investment in G&LIT infrastructure and protocols.

AgilityG&L will provide rapid ramp-up, scalability and flexibility in order toexceed client’s requirements. Shift patterns can be deployed to ensureoptimal time zone efficiencies with global stakeholders.

Our Commitment to Clients

DiversityThe G&L culture is one that iscommitted to, and supports

unequivocally, gender equality andhuman rights, irrespective of colour,

class, creed, orientation or thenumerous other defining traits that

make us who we are as uniqueindividuals.

Equality of OpportunityThe cornerstones, values and guiding

principles of G&L are – and always will be –based on equality of rights and

opportunities. We are passionate aboutensuring our principles are upheld andproactively ensure this through our own

HR and Resourcing functions. Wechampion equality and diversity through

our business dealings and day-to-dayoperations.

Equality of Opportunityues and g

l

Equality of Opportunitylue d gu

alwgu

ways will behts andonate abou

pheld a

Equality of Opportunityiding

be –

tre up

through ofunctions.diversity t

d d

are ups th og .d d y t

nd da

is

hello@gandlscientific.com www.gandlscientific.com

CONTACT US