About Pharmalink

Your presentation today

 Pharmalink
 Profile & Capabilities
 Global Regulatory Experience
 Project Experience – Case Studies
 Additional Capabilities
 Summary

Who we are

 Founded in UK in 1998
 Privately held
 Leading independent Regulatory Affairs
Specialist
 Offices in Europe, US, India and Asia-Pacific
 155 Staff as of May 2011
 Large, proprietary network of freelance RA
professionals worldwide
 Revenues in excess of $25 million in 2010

Who we work with

 18 of top 20 healthcare companies
 Large pharmaceutical multinationals
 Consumer Health organizations and divisions
 Biotechnology & new technology
 Clinical research organizations
 Medical device companies
 Generic companies
 Start-up ventures
 Virtual companies

Consumer Profile
Pharma

Biotech

Medical device

Consumer Health

Veterinary

Generics

Nutraceuticals/Other

What we can help with

 Projects of any scale or duration
 Domestic, international and multinational
projects
 Interim regulatory staffing needs
 Assistance at all stages of regulatory lifecycle

What we can help with

Non-clinical

Clinical Development

Pre-Submission Activity

Filing / Submission

Approval

Product Launch

Post-Approval

RA Solutions that fit your business

REGULATORY Regulatory Strategy Clinical Advertising &
Promotion/Labeling
SERVICES Regulatory agency Preparation of
meetings CTD Module 2 & 5 USPI/PLR/SPC/CDS
Filing strategy Review of protocols & User testing
Response to agency CSRs Packaging
queries CTA preparation
Advisory Committee Review of IBs
preparation Regulatory Operations
CMC & Manufacturing IRB/EC documentation
Scientific Advice
Compliance Orphan indication CTD/eCTD/dossier
Lifecycle management preparation
Pediatric development
Gap analysis & remediation Input from Subject Matter plans Submission advice
Experts
Preparation of Amendments Translation service
CTD Module 2 & 3 Medical writing
Filing Expertise
DMF preparation GCP audit Non-clinical
Validation IND/IMPD
TPM site identification Original NDA/MAA Postmarketing Maintenance Preparation of
Contract QP ANDA CTD Module 2 & 4
Import documentation and sNDA/variations Review of toxicology &
BLA pharmacology studies
licensing Annual Reporting
510K/PMA
GLP/GMP audit Postmarketing Commitments
Pre-approval inspections Safety reporting eg PSUR

RA Solutions that fit your business

A Regulatory Affairs team for
all your regulatory needs

 Junior consultants to Subject Matter Experts
 Generalists to specialists
 Assistance with projects of any scale and
length
 On-site or remote working on Domestic,
International, and Multinational assignments

How we work

 Project are served by appropriate experience
– 30+ yrs to 1 yr depending on requirements
– Mainstream or specialized experienced
– Industry and/or Agency expertise

 Senior Regulatory Managers assisted by
junior level staff for data intensive work

3. Global Regulatory Experience

Global experience
Our consultants have experience in the
following regions:

Europe (EU, Switzerland, Norway, Iceland)
Middle East and Africa
North America and Canada
Central America and Caribbean Community
Latin America
Central & Eastern European states
Australia & New Zealand
Asia-Pacific

Global Pharmalink Offices
Cambridge, MA
Short Hills, NJ
King of Prussia, PA Maidenhead, UK

Singapore

San Francisco, CA

Mumbai, India
Hartford, CT
Washington, DC
New York, NY
Durham, NC

Pharmalink Affiliate Network

L o ca l Re g u l ato r y A ffa i rs Wo r l d w i d e


 Access to local Regulatory Affairs
expertise when and where you need it.
 The best Regulatory Affairs professionals in every
continent.
 Covering every market from Argentina to Zambia.
 Leading local consultants who:
– understand the culture
– will ensure your requirements are met
– save you time and money.


NORTH AMERICA

CANADA
UNITED STATES: NJ (US HQ) | MA | CT | NY | PA | NC | CA | DC

Case Study 1

Major regulatory compliance project
CLIENT A major pharmaceutical company based in Europe.
PROJECT A large compliance project.
OBJECTIVE Review all European-registered licenses and bring into
compliance with current manufacturing site practices.
SOLUTION Pharmalink provided a dedicated team of regulatory affairs
specialists to work on the project for 3 years.
One of the key advantages that Pharmalink was able to bring to the project
was the ability to adjust the number of consultants working on the project to
fit the client’s needs and hit every deadline whilst always maintaining the
level of quality.

Case Study 1

Project Details

 Consultants reviewed registered details against manufacturing site
documents, highlighting compliance issues.
 Consultants worked with site QA departments in preparing remediation
plans for each license.
 Over 600 licenses were reviewed and each phase of the project was
delivered to the client’s timelines.
 Pharmalink’s staff exceeded the client’s expectations on each phase of
the defined project, resulting in the client engaging Pharmalink to
prepare all of the Variations and submit to all EU agencies in order to
bring the product licenses into compliance.

Case Study 2

Global Product Compliance Project
CLIENT Top 10 Pharma Company.

PROJECT Since 2004, Pharmalink Consulting have been successfully
performing a large-scale Global Quality Compliance program for a
company, covering approximately 1400 Quality Dossiers
worldwide.
OBJECTIVE
Short term – get product moving around Europe again.
Long term – bring all dossiers and licenses up to date providing
sustainable compliance.
SOLUTION
The team that Pharmalink Consulting assembled has successfully
driven all key stages of the compliance process including:
– Quality Dossier collection and collation into
CTD format
– CMC Compliance Assessment
– Product Remediation

Case Study 2

Project Details

 Dossiers Collected – 270
 Dossiers Collated – 270
 Compliance Assessments Performed - 270 (10% TPM)
 Remediation Packages Prepared – 564
 Markets -

AT, BE, BU, CH, CY, CZ, DE, DK, EE, EL,ES, FI, FR, HU,
IE, IS, IT, LT, LV, MT, NL, NO, PL, PO, RO, SE, SK, UK

Case Study 2

Project Details
 Throughout the compliance project in Europe, the Company was forced
to halt product shipment until gap analysis was completed. This put
enormous pressure on the team, yet the impact on product shipments
remained minimal.
 Various stages of the compliance process were performed remotely from
the client, across the Pharmalink offices in North America, Europe and
Asia. All objectives and milestones were successfully achieved ahead of
target dates.
 The Pharmalink team reached 45 in number at the height of the activity
but remained flexible dependent on the workload so were able to adjust
accordingly. Pharmalink was able to offer office facilities for the purposes
of the project.
 The resulting completion of the European section of the project meant a
satisfied client who has continued to employ Pharmalink for regulatory
activities across multiple sites in Europe and the United States.

Case Study 3

Organization Acquisition Project


PROJECT Since 2004, Pharmalink have been involved with a large scale
global integration project.

OBJECTIVE Short term – Assemble and assess documentation.
Long term – complete ownership changes and related regulatory
activity to bring dossiers and licenses in line with parent company.
The team that Pharmalink Consulting assembled successfully enabled
license transfer and documentation incorporation all key stages of
the compliance process including:
- data gathering - reviewed existing documentation, job descriptions,
SOPs, job aids, interviewed staff
- Mapped process(es) - deployment,
interactions, comparison against best practice
- Recommendations presented to sponsor –
Appropriate to the organization concerned

Case Study 3

Project Details
 Project sponsorship – It was important to get high level buy-in and support and
confirm mutual understanding of deliverables and objectives. At an early stage
effective communication and ‘marketing’ of activities was developed to overcome
potential issues.
 Environmental issues – Given the cultural differences between sites, areas of
organisation Pharmalink worked with the project sponsor to identify the potential
roadblocks to a successful outcome – Often M&A ‘fallout’ can present barriers to
success.
 The Pharmalink team adjusted the resources at various stages to deal with short
term increases in workload, but remained flexible. Pharmalink was able to offer
office facilities for the purposes of the project.
 The resulting completion of the integration meant that the organization was able to
operate a ‘business as usual’ model, despite the uncertainty and disruption
associated with many mergers and acquisitions. A satisfied client who has
continued to employ Pharmalink for regulatory activities across multiple sites in
Europe and the United States.

Case Study 4

Merger & Quality Compliance Project
Large Pharmaceutical Company

PROJECT Since 2000, Pharmalink Consulting have been engaged in an
operational role in a license integration, site rationalization, and a
quality compliance project.
OBJECTIVE Short term – Assist client company meeting legal and commercial
obligations and targets as a result of merger.
Long term – complete source transfers and related regulatory activity
to enable seamless supply chain.
SOLUTION The team that Pharmalink Consulting assembled successfully enabled
license transfer and documentation incorporation all key stages of the
compliance process including:
– site transfers including internal and TPM sites,
covering markets worldwide.
– Performed quality & compliance reviews.

Case Study 4

Project Details
 Pharmalink was the operational regulatory partner in the UK and US for site
rationalisation and product quality compliance resulting from a high profile
merger between two large pharmaceutical companies. The key performance
indicator was the need for cost saving and manufacturing rationalisation –
central to these activities.
 Pharmalink was tasked with identifying requirements, timing, and delivering site
transfers for worldwide markets. In parallel with this activity the team completed
a quality compliance review on all products that enabled a full regulatory strategy
to be available when sourcing decisions had to be made.
 The Pharmalink core team of 25 was adjusted as requirements varied and
reached 60 at its peak. Following the merger activity in 2005 Pharmalink has
maintained smaller team to continue routine source transfers.
 The volume and complexity of the project was managed successfully and key
merger targets achieved. The client was satisfied and continues to employ
Pharmalink for a variety of regulatory activities across its sites.

What else can we offer you?

 High Quality Translation Service in 100+
Languages

 Operations and publishing - eSubmissions


1. We have demonstrable capability and
experience with large scale multi-product,
multi-national regulatory projects on
behalf of Top-20 healthcare companies.
Our familiarity with such sizeable projects
provides our clients with assurance that
the desired results can be achieved for any
project of any size.


2. Our global regulatory teams are comprised
of consultants with a wide range of skills
and levels of experience.
This allows us to be able to meet client
requirements while ensuring that costs are
kept to a minimum by using the right level
of consultant for the various tasks.


3. The infrastructure, both in terms of systems
and people, that we have established and in
which we have invested, underpins our
ability to undertake projects of varying scale.
We have a purpose-built, centrally-managed
IT network for all of our offices worldwide.
This will ensure peace of mind as we are
able to segregate and secure individual
company data while allowing for flexible
access.


4. Whilst Pharmalink Consulting is now a
multi-national consultancy that is
recognized as a global leader in Regulatory
Affairs, we remain nimble and flexible to
react to our clients’ often urgent
requirements.

About Pharmalink

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