The document describes GMP Compliance Consultants, a team of experts providing quality and compliance consulting services to the pharmaceutical and food supplement industries. They have a team of over 15 highly experienced individuals with over 350 years of combined experience across areas like quality assurance, validation, technology transfer, and regulatory compliance. They offer a wide range of services including project management, technology transfer, validation, quality system implementation, auditing, investigations, and training. Their goal is to help clients ensure their products and services meet regulatory standards through reliable, knowledgeable expertise.

1. www.gmpcom.com
We are GMP
Compliance
Consultants to the pharmaceutical and
food supplements industry.
Your trusted quality & compliance
solution provider.

2. Meet the key players...
We are a team of highly
skilled and passionate
individuals who together
offer a valuable support and
consultancy service to the
pharmaceutical and food
supplement industry. We
truly love what we do.
And it shows. We get it right in an industry where
getting it wrong is not an option. Our clients feel
secure in the knowledge that we have the right
experience, qualifications and drive to deliver
the right results.
Our team is everything and we are constantly
improving and growing. Although we exist in
a world of process and procedure we strongly
believe that people are our most important
resource.
Even as the
company is
expanding rapidly,
the atmosphere is
fun and exciting. No
day in the office is
the same. Every day
is a new learning
experience where
we learn from
and teach each
other. Every single
employee is willing
to help and extend
their expertise for
the betterment of
team and the end
result.
Rachael Davies
Quality and Compliance
Manager
Rachael has 12 years of
experience within QC
management, quality
systems management and
vendor assurance within the
pharmaceutical, medical
device and food supplements
industries.
Karen Ollett
Technical Manager
Karen has over 27
years’ experience in the
pharmaceutical and food
supplement industry. She has
held various management
positions within procurement,
supply chain and artwork
management.
Mark Burgin
Technical Manager
Mark has over 11 years
experience in the
pharmaceutical, medical
device and food supplement
industries. His roles include
microbiology management
and GMP oversight. Mark is
Lean Six Sigma trained and has
an in-depth knowledge of root
cause investigation, deviations
and CAPA management.
Graham Gledden
Technical Leader
Graham is a professional
electrical /mechanical
engineer with 36 years’
experience working across
various industries including
marine, heavy industry, food
and pharmaceutical.
Jenny John
Project Leader
A passionate professional
with 5 years of experience in
project management, business
administration, project
coordination and quality
management systems.
Giby George
Senior Consultant and
Managing Director
A passionate professional
who truly cares for his team
and clients. Giby has over
20 Years’ experience in the
Pharmaceutical and Food
Supplement industries. He
has held senior management
and technical positions in
QA, Manufacturing, Quality
Control, R&D, marketing and
business development in the
UK and overseas.
He is qualified to act as a
‘Qualified Person’ within the EU
under permanent provision.
A little
bit
about
us

3. A little
bit
about
what
we do
Our knowledge and
experience shows in our list
of services - it’s extensive.
But you can feel confident
that we have every area
covered...
We have extensive
experience.
We can streamline
your processes
and help to
prevent problems
occurring and
deliver brilliant
results.
Pharmaceutical
Project Management
If you are making big changes in your business
and need first class input and support, we can
help with any and every aspect:
• Expanding your business
• Closing/decommissioning a site
• Introducing a new formulation or new/different
manufacturing capability
• Creating a virtual operation
• Importing API’s & license products
• Reconstructing your business
• In need of formulation and quality & compliance
remediation
• Introducing clinical trial projects
Technology Transfer
Technology transfer is a process that spans the
key phases of pharmaceutical development
right through to commercial manufacturing
including:
• Product transfers including API and drug product
manufacture
• Processing, packaging and cleaning operations
• Quality control – analytical method transfer
We offer a complete solution for Technology Transfer
(TT). Our dynamic and experienced technical, QC
and QA teams have the ability to manage all your TT
requirements without an increase in headcount. We
can provide TT services in an optimum time scale with
rigorous efficiency.
• Technology Transfer
• Validation
• Pharmaceutical Project Management
• QP services
• PQS
• Auditing
• Quality Investigation
• Regulatory activities
• Training
Validation
GMP Compliance has substantial experience
in specialised contract validation services
including facility, process and product validation
and revalidation.
We can manage all your validation requirements from
project management to report writing. Our experienced
validation engineers can be based in your facility
to execute validation testing and work with you to
streamline the testing to increase efficiency and optimise
testing value.
• Equipment validation
• Process validation
• Validation protocol development/report/field
execution
• Product validation
• QC/microbiology method validation
• Cleaning validation
• Revalidation

4. We are
focused on
ensuring that
our clients’
products
and services
meet or
exceed the
expectations
of their
customers
A little
bit
more
about
what
we do
QP services
We provide a range of QP services and
consultancy support to the pharmaceutical
industry. Our Team has a strong knowledge and
skills base in these areas and we make a great
partner for companies who outsource for this
kind of support
• Contract QP cover
• QP training, mentoring and due diligence
• Product release
• API QP audits and certifications
• CMO audits
• Management of regulatory inspections
• Quality system review and implementation
• Risk management
• Supplier assessment review and management
Auditing
Our auditing process encompasses unique
tools and techniques based on best practice
guidelines and detailed background
research.
We ensure that our auditors have the ability from
a commercial, technical and GMP point of view
to identify genuine risk and potential risk. We have
hands-on experience in Global Supply Chain
from a wide range of regulatory authorities. GMP
Compliance can offer guidance and practical
support in the following areas:
• Site audits and qualification of API manufacturers
in compliance to ICH Q7, excipient manufacturers,
contract manufacturers and suppliers, packaging
and labelling contractors, warehouse contractors
and contract laboratories.
• Site audits of finished products
• Pre-inspection approval assessments
• Auditing facilities to ensure an appropriate level of
due diligence
• Pre-regulatory assessment audits and gap analysis
• Mock regulatory audits
• CMO fact finding inspections and investigative
inspections
Our third-party audits meet the highest standards in
quality and independence.
Pharmaceutical
Quality System (PQS)
The GMP Compliance team can provide
experienced QA Specialists performing quality
assurance services tailored to your needs at low
costs in a time-efficient manner.
At GMP Compliance, we are focused on ensuring that
our clients’ products and services meet or exceed the
expectations of their customers. We plan and execute a
coordinated set of activities that direct and control quality
processes, whilst maintaining delivery schedules and
price of our services. This requires improving systems,
processes and resources that deliver and support your
products and services.
Our services include:
1. Generation, Implementation and improvement
of PQS
• Deviation/OOS
• Change control
• Risk assessment
• Customer complaints management
2. Project management
• Project design and implementation
• GMP project assessment
• GAP analysis
• Change management
3. Regulatory compliance support
• MHRA, FDA, EMEA and other regulatory body
inspection preparation
• Audit management
• GAP assessment
• CAPA management
• Risk mitigation support
• Training
4. On-site resource for backlog management
• Risk mitigation
• CAPA management
• Change control management
5. Interim quality management support
• Design and implementation of PQS
• Vendor assurance
• CAPA Management

5. The training is
based on hands
on experience of
where things have
gone wrong and
the root cause
behind it. We
also make you
think about how
to plan, design
and implement
projects
with sound
microbiological
understanding.
Learn the bugs
before you get
bugged!
A little
bit
more
about
what
we do
Quality
Investigations
We offer an independent open-minded and
experienced resource to come and support
your team in facilitating detailed root cause
assessment and CAPA implementation
plans. We recognise the importance of a
structured approach to conducting root cause
investigations and can provide guidance and
support in this critical area.
• Generation and improvement of QMS
• Implementation of pharmaceutical QMS
• Redesign of QMS to incorporate major changes and
changing business needs
• QMS for virtual operations
Training
We can create and provide a wide range of
training for your needs. Our training packages
are custom made to ensure you get the
desired benefit. It is very interactive to ensure
that the trainees achieve the desired levels of
understanding. We can provide CPD and topic
specific training on the following;
• GMP training
• QM training
• CPD training
• Microbiology and contamination management
• Continuous improvement and Lean Six Sigma
• Pharmaceutical water systems
The training is based on hands on experience of where
things have gone wrong and the root cause behind
it. We also make you think about how to plan, design
and implement projects with sound microbiological
understanding. Learn the bugs before you get bugged!
Regulatory activities
Our regulatory team is from both the
pharmaceutical industry and food supplement
industry covering both UK/EU and international
registrations.
• Regulatory submissions for marketing and quality
certification
• EMA/FDA etc product compliance
• Provision of scientific data for regulatory applications
and submissions
• Submissions for new product licences and licence
variations and renewals
• Preparation of accessible product labels, patient
information leaflets and storage specifications
• Planning and development of product trials and
interpretation of trial data
• Advice for scientists and manufacturers on regulatory
requirements throughout the development of a new
product
• Management of regulatory inspections

6. And
finally...
We will conduct
every aspect of
our business with
honesty, integrity
and openness,
respecting the
interests and
needs of our
employees and
customers.
Our knowledge and
experience
To ensure that we have great knowledge and
experience across all the areas in which we
operate, we have chosen our team carefully
and we are proud to have over 350 years of
combined experience in the following areas
within our company.
• Combined QA management experience of over 70
years across a number of different industries
• Combined experience of over 40 years in
validation, electrical and mechanical
engineering
• Technology transfer expertise for product
portfolios to a multitude of CMOs
• Expertise in microbiological risk
management and gap analysis
• Over 10 years’ experience in QC and
micro QC management across a range
of dosage forms and sectors
• Expertise in analytical and microbiological
method validation in line with ICH
guidelines
• Over 10 years of QP experience on active
licences across a wide product range
• Generation of vendor assurance
programmes and risk management of
global supply chains
• Trained and competent auditors covering
all supply services
The GMP Compliance team is
made up of highly skilled and
passionate professionals with
a broad and varied range of
experience.
Our key to each successful project is the team
work that prevails throughout the company. Each
team member is always willing to help and people
are actively encouraged to share their ideas and
experiences.
We strongly believe in continuous development
and keeping our team members up to date,
competent and well trained thereby ensuring that
our clients receive top quality services.
Core Values
We care
We don’t just want your business - we want to be a part
of your business - because we care passionately about
the results we deliver. Mediocraty is not an option on
any level.
We work as a team
We are a strong and cohesive team and when we work
with you we hope to become an integral part of your
team. We respect our colleagues, our customers and
the environment. Teamwork is vital to what we do.
We have the relevant
knowledge
We operate in a highly regulated industry where
mistakes cost money and potentially lives. We take
knowledge, training and experience seriously - we have
all of the relevent skills to make sure mistakes don’t
happen.
We take ownership
You will never see us walk away from a project until it is
completed to your satisfaction. We have high standards
and we stick to them, always.
• We work as a team taking ownership and
accountability for the outcomes of all our actions in
providing the best fit solution for you.
• Every service and solution that we provide for you,
we try to ensure that they exceed your expectation.
• As a team we are more than happy to do whatever
it takes to fulfil your vision and objectives as they
are our commitment.
We are positive
Like most people we like to feel happy and enjoy our
work. We have a positive mindset and attitude and like
to smile - even in the face of adversity! We like clients
to enjoy working with us - it’s important.

7. Our
Services
Get in touch
T: +44 (0) 1482 797 171
M: +44 (0) 7549 613 010
E: info@gmpcom.com
W: www.gmpcom.com
HEAD OFFICE (ADMINISTRATIVE OFFICE)
Compass House,
17-19 Empringham Street,
Hull HU9 1RP, UK
OPERATIONAL OFFICE
1301 Hedon Road, Hull HU9 5NJ, UK
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Contract
QP
Services
Technology
Transfer
Regulatory
Services
Quality
Management
Investigations
Validation
Services
Stability
and
Storage
Management
API and
supplier
audits
GMP and
QA
Training