4. Who we are
Founded in UK in 1998
Privately held
Leading independent Regulatory Affairs
Specialist
Offices in US, Europe, India and Asia‐Pacific
155 Staff as of January 2011
Large, proprietary network of freelance RA
professionals worldwide
5. 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
6. Consumer Profile
Pharma
Biotech
Medical device
Consumer Health
Veterinary
Generics
Nutraceuticals/Other
8. What we can help with
Small to large scale projects
Domestic, international and multinational
projects
Short to long term projects
Interim regulatory staffing needs
Assistance at all stages of regulatory lifecycle
9. What we can help with
Non‐clinical
Clinical Development
D ru
g Di Pre‐Submission Activity
scov
e ry
Filing / Submission
Approval
Product Launch
Post‐Approval
10. 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
11. 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
12. How we work
Project are served by appropriate experience
– 1 yr to 30+ 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
14. 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
17. Pharmalink Affiliate Network
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.
18. Pharmalink Affiliate Network
EUROPE
AUSTRIA | BELGIUM | CYPRUS | CZECH REPUBLIC | DENMARK | FINLAND
FRANCE | GERMANY | GREECE | IRELAND | ITALY | NETHERLANDS
PORTUGAL | SPAIN | SWEDEN | SWITZERLAND | TURKEY | UK (GLOBAL HQ)
20. Pharmalink Affiliate Network
AFRICA
ANGOLA | BOTSWANA | DEMOCRATIC REPUBLIC OF CONGO | LESOTHO
MADAGASCAR | MALAWI | MAURITIUS | MOZAMBIQUE
NAMIBIA | SOUTH AFRICA | SWAZILAND | TANZANIA | ZAMBIA | ZIMBABWE
21. Pharmalink Affiliate Network
EASTERN
EUROPE
ALBANIA | AZERBAIJAN | BOSNIA & HERZEGOVINA | BULGARIA | CROATIA
ESTONIA | GEORGIA | HUNGARY | KAZAKHSTAN
KOSOVO | MACEDONIA | MOLDOVA | MONTENEGRO | POLAND | ROMANIA
RUSSIA | SERBIA | SLOVAKIA | SLOVENIA | UKRAINE | UZBEKISTAN
22. Pharmalink Affiliate Network
ASIA PAC
AUSTRALIA | CHINA | HONG KONG | INDIA
JAPAN | MALAYSIA | NEW ZEALAND | PHILIPPINES | SINGAPORE
SOUTH KOREA | THAILAND
26. 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.
27. 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.
28. Case Study 2
Biosimilar Product Review
CLIENT A major pharmaceutical company based in Europe.
PROJECT Review and update of a Module 3 and Quality Overall
Summary for a Biosimilar product in preparation for one of
the first European submissions of its type.
OBJECTIVE Document submission.
Speed to market was of high priority to the client.
SOLUTION Pharmalink was able to turn to one of its experienced
consultants with a track record specifically with the biotech
product in question.
29. Case Study 2
Project Details
The consultant reviewed and updated submission documents and
provided a pragmatic corrective action listing whilst preparing key parts of
the filing.
The consultant added value by preparing a risk analysis alongside the
required output, thus ensuring that the client was aware of potential
issues once the filing was undertaken.
Work delivered to the client less than a month after the documents were
received by Pharmalink.
Pharmalink completed the task by reviewing the project with the client,
providing an online facility to feedback on the experience and ensure a
satisfactory service, at no cost to the client.
The client submitted the documentation with understanding
of the road ahead.
30. Case Study 3
Multinational clinical trial sponsor & Clinical
Research Organization
CLIENT Sponsor and CRO.
PROJECT Provide regulatory support for a clinical trial including new
submissions for the trial in multiple markets.
OBJECTIVE Submit the clinical trial in multiple locations in a timely
manner to allow trial initiation.
SOLUTION Pharmalink provided consultants with valuable local
knowledge to add to the regulatory intelligence of submissions
in each market.
This project was a testament to the lengths to which the team
went to understand the brief and work with the client
to achieve their goals.
31. Case Study 3
Project Details
Multinational program ‐ 9 markets
– Europe FR, UK, DE, PL
– Eastern Europe Russia, Ukraine
– Middle East Egypt, Israel
– Asia India
The challenge was to guide a US‐based sponsor through the
regulatory procedures and processes, different in all markets,
whilst work with multiple vendors in areas such as safety
reporting, ethics submissions and so forth.
Pharmalink fulfilled the requirements and submissions completed
to date have been filed according to the planned schedule.
32. Case Study 4
Global Product Compliance Project
Large Pharmaceutical Company
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
33. Case Study 4
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
34. Case Study 4
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.
36. Permanent Staffing
Pharmalink Consulting, the regulatory affairs
specialists since 1998, introduces a unique
regulatory recruitment solution
Pharmalink has unrivalled access to permanent
regulatory affairs candidates throughout the industry.
All of our candidates have been interviewed by Senior
Regulatory Affairs professionals familiar with client
needs.
We can offer optional interim staffing by one of our
regulatory affairs consultants while we identify
your ideal permanent employee.
37. Permanent Staffing
The Pharmalink Permanent Solution 6 Step Plan
STEP 1 STEP 2 STEP 3 STEP 4 STEP 5 STEP 6
[optional]
You Contact Pharmalink We research Pharmalink Following
identify a Pharmalink, can provide our provides a selection,
permanent where an an extensive selection of your new
recruitment experienced experienced portfolio of chosen member
need regulatory consultant to regulatory candidates of staff
affairs act as an affairs for you to commences
professional interim professionals meet and role
will discuss member who have consider
your of staff while previously
requirement we identify been
and take a your ideal screened and
detailed brief permanent vetted
employee
38. What else can we offer you?
Resource backup and alternative, flexible
ways of working from regional hubs
Local knowledge on a global scale
High Quality Translation Service in 100+
Languages
A company accredited with QMS ISO 9001
A company accredited with IIP status
Recently completed a $2.4 million investment
program
Electronic publishing ‐ eSubmissions
40. Our offering in summary
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.
41. Our offering in summary
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.
42. Our offering in summary
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.
43. Our offering in summary
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.
44. Thank you
USA: + 1 800 434 5808
SHORT HILLS, NJ | CAMBRIDGE, MA | HARTFORD, CT | MANHATTAN, NY | KING OF PRUSSIA, PA
DURHAM, NC | SAN FRANCISCO, CA | WASHINGTON, DC
UK: + 44 1628 860300
MAIDENHEAD, BERKSHIRE
INDIA: + 91 22 4030 9595
MUMBAI
SINGAPORE: + 65 6408 0515
