DArcy Consulting Overview

Corporate Overview and Capabilities
“… We Build Compliance Cultures …”
105$Spencer$Road,$PA$19333$4 Telephone:$(610)$24146983$4 Catherine@DArcy4Consulting.Comwww.darcy4consulting.com

Catherine Arthey, Founder is an experienced consultant with over 20 years
of consulting experience in Pharma, first with PA Consulting Group and then with
Deloitte, where her focus has been predominantly Clinical, R&D, Corporate and
Commercial Compliance.
! Catherine’s passion is working with small/ mid size companies and simply helping
them become compliant by establishing the necessary infrastructures to
accommodate and facilitate success in the marketplace
! She helps companies reduce risks associated with their day to day operations. Gap
assessments, risk assessment, process development, Policy/ SOP development as well as
training are core offerings from DArcy Consulting.
! Catherine has also created Compliance Operation models and Compliance
Programs for Companies seeking to build a Compliance function.
! Catherine is a superb facilitator.
Our Team

Jane Reagan is a seasoned pharmaceutical Consultant with over 25 years experience
in the industry including R&D, Clinical, Supply Chain, Manufacturing and
Commercial Compliance.
! In a major role with a Pharmaceutical Company, Jane was responsible for R&D policy and
SOP development and review; she was responsible for designing, implementing and
maintaining policies and procedures to ensure compliance with clinical trial disclosure
requirements.
! Jane also held managerial responsibilities within a training and development function
where she implemented a new discipline to promote a culture of training and compliance.
! Jane’s focus is predominantly Compliance within the Life Science environment. She excels in
conducting document gap assessments, developing policies & SOPs, developing and
rolling out training.
! Jane has superb project management skills.
Our Team (Continued)

Who We Are
Simply put DArcy Consulting enables your organization to become
more compliant. Whether your business is pharmaceuticals, biologicals
or devices, it is our belief that compliance is not tax on your business but
rather a critical business enabler. Compliance is about doing things
right and doing it ‘right the first time'. Making sure individuals are
trained to work in an ethical way and know to make the 'right choices' in
their work. Having the right business processes in place to ensure
activities are done right first time and in a compliant way. With
compliant business processes comes repeatability, with repeatability
comes consistency, with consistency comes performance. This is
why we believe Compliance can drive Strategic Performance.
Our Consultants can work with you to explore better ways of working that are compliant and efficient. We
establish the governance, processes, polices, sops and operating model to ensure regulatory requirements are
met thus enabling businesses to drive to higher performance.

Our Services
! Our services are totally wrapped around making our
clients compliant and efficient. For Life Science
organizations, we offer services around Compliance Gap
Assessment, Risk Assessment, Process Development,
Policy & SOP development as well as General Program
Management to support our listed services.
! With our deep industry experience, strong consulting
toolkit, we offer grounded, practical, risk based
implementable solutions.
Our clients are not training grounds for inexperienced
consultants. They are the platforms from which we
drive compliance and value throughout our Client
organizations.

Our Work
! Over the years our team has helped life science companies reduce their
compliance risks while increasing overall business performance. While
our approach varies, our clients enjoy similar experiences – Measurable
Success. Projects completed over the last year for start up/ mid size life
science companies include:
- Clinical Compliance gap assessment
- R&D Risk Assessment
- Policy/ SOP development
- Inspection Readiness assessment (& development of Inspection
Readiness guidelines)
- Audits
- Assessment for ICH E6(R2) readiness & requirements
- Commercial Compliance gap assessment
- Compliance benchmarking
- Assessment of TMF prior to inspection
- Development of multiple corporate/ commercial compliance policies
- Assessment/ benchmarking of quality management systems
- Compliance Operating model development

Typical Projects – Clinical Compliance
! For a start up biotech company in advance of its first filing, we conducted an
Assessment of its Clinical Compliance. The client also wanted to be aware of any
gaps in its Clinical program in order to be prepared for regulatory agency inspections.
As part of the assessment we identified gaps in process and procedures which we helped
to address prior to filing.
! For a mid-sized pharma company, DArcy Consulting established business processes
and supporting sops for a number of the client’s key clinical processes including
Protocol, Informed Consent, CSR as well as Statistical Analysis Plans.
! For a start up biotech, we assessed its Clinical SOPs for alignment to ICH E6 R2
requirements and made the necessary updates. We also conducted a TMF
Assessment. For that client we also created a set of Inspection Readiness Guidelines.
! For a company that received a warning letter, we undertook a complete review of its
Biometrics function (Data management, Statistics and Statistical Programing). As a
result of an internal survey, we were able to identify specific gaps and put in place
solutions to address gaps (organizational structure, training, SOPs).

Typical Projects – R&D Compliance
! For a start up biotech in advance of its first filing, we conducted a Compliance
Gap Assessment of its entire R&D group. Gaps were identified across key
documents and processes. DArcy Consulting worked with the client to close
identified gaps in areas such as Policies & SOP and training.
! For a start up biotech company, we developed the Entire Suite of SOPs for
Clinical, Regulatory, Pharmacovigilance and some Medical Affairs.
! As part of an M&A for a pharma client, we coordinated and supported the transfer of
all policies and SOPs to the acquiring company’s QMS. This included
systematically going through all 2,000+ documents to determine what would be
kept for ongoing studies or retired.
! For a company that had received a 483, we developed the business processes and
documents to transform the Medical Writing Function – ultimately establishing a
process for timely and efficient completion of the Clinical Study Report.

Typical Projects – Corporate Compliance
! For a start up biotech company, we developed a range of policies
across HCP engagement, business communication, interactions
with consultants, social media, Aggregate spend etc. We also
developed a suite of e-learning to support the roll out of the
policies.
! For the head of Corporate Compliance for a mid size-pharma
company, we developed a simple automated risk management
process and supporting dashboard.
! We helped a Corporate Compliance group in advance of the
Company’s CIA by creating the program framework,
reporting mechanism and individual project templates. Across
the 24 individual CIA projects, we supported the development of
processes and SOPs. We also managed the PMO and weekly
leadership updates.

Typical Projects – Commercial Compliance
! For a mid size Pharmaceutical Company, we conducted an assessment of its
Commercial Operations Compliance Controls. We also conducted an
assessment of its control documents and systems. We identified gaps in key
processes such as professional engagement and SOPs.
! For a biotechnology company, we performed an assessment of the grants
function. We developed a number of business processes and supporting documents
to cover the role of the grants function as well as the business processes that not only
govern its operations but which make it compliant to agency requirements.
! For a pharmaceutical company, we performed an assessment of the publications
policy and supporting processes to determine the level of compliance. We
subsequently developed robust business processes and sops to govern the operations
of the publications group and ensure it was compliant with agency requirements.

Typical Projects – Manufacturing Compliance
! As part of an M&A activity, we supported the integration
of Technical Operations and Quality Documents
(guidelines and some SOPs). Working with teams, we
facilitated the process of document retention and
document transfer to our client’ s quality management
system.
! For a start up pharmaceutical company, from the time of
its first filing until product launch, DArcy Consulting
worked with the client to close Identified Gaps in
Quality and Pharmaceutical Development by assisting
with Policies & SOPs.

Typical Projects – Research Compliance
! For the head of Pre-Clinical Research of a mid-size
pharma company, we created Regulatory Submission
Templates to ensure that pre clinical materials were
submission ready, compliant and reported in a consistent
format.
! As part of an M&A activity, we supported the integration
of clinical research documents (guidelines and some
SOPs).

Testimonials
“DArcy Consulting provided excellent structure at the beginning of the project to understand what changes
were required as a result of being under a CIA and how to implement them. Very strong in laying the
foundation for the project, assigning accountabilities and ensuring deliverables were met. It has been a
pleasure working with Catherine in the last few months. I have admired her passion, commitment and
knowledge of the industry and our environment here and I am still amazed at the amount of work that she
has been able to handle. I hope our paths will cross again” –
Senior Director (Pharma Company)
“Dear Catherine, very many thanks for your leadership of this project. I’ll say now, an ambitious project that required
continual drive and exceptional customer/supplier engagement. You did a great job on all front. I’m extremely pleased with the
outcome.” – Senior Director (Pharma Company)
Jane Reagan of DArcy Consulting demands excellence and delivers on it in her preparation and drafting of procedural
documents and associated training. The policies and training I have developed collaboratively with her inform stakeholders
of the why and how to be compliant with FDA healthcare regulations. Experts, like Jane, navigate our commercial and
medical stakeholders to execute their activities with integrity and confidence in what is a highly regulated industry. We are
all the wiser for her commitment to simple, but impactful compliance guidance.
Compliance Business Partner (Start Up Biotech)

In addition and when needed, we leverage the use of strategic consulting partners to
supplement our team. In this way we can remain agile, efficient and cost effective.
Strategic Partnerships
Consultant 1
! Clinical and
Pharmacovigilance
! Clinical Quality
Assurance
! Audit & Monitoring
! Expertise with ICH
! Vendor management
Consultant 2
! Advanced analytics
! Analysis and
visualization
! Dashboards
! Advanced modelling
Consultant 3
! Training &
development
! E-Learning
! Communications
! Change management

www.darcy-consulting.com
Contact Us
Thank you for the opportunity to serve your company’s need and we look forward
to hearing from you. If you have any questions, please do not hesitate to contact us
Catherine@darcy-consulting.com
Jane@darcy-consulting.com

DArcy Consulting Overview

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